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A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care (PREFER)

Primary Purpose

Chronic Heart Failure (CHF)

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Standard care

About this trial

This is an interventional other trial for Chronic Heart Failure (CHF) focused on measuring low-interventional observational study,, CHF,, heart failure,, primary care,, ESC guidelines,, Europe,, NT-proBNP,, reduced ventricular ejection fraction (EF),

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing and able to provide written informed consent and accept study procedures and time schedule.
Age ≥ 18 years.
Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).
Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.

Exclusion Criteria:

Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.
Cancer or other significant co-morbidities implying that the patient's condition is unstable.
Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR < 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
Patients who are primarily managed and regularly followed-up by a cardiologist for their HF
Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients' heart failure and non-heart failure

Arm Description

No treatments are stipulated by this protocol - patients' HF and non-HF treatments will be observed throughout the study. The patients' treatment is entirely in the discretion of the primary care physicians

Outcomes

Primary Outcome Measures

Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)

Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.

Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose

Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF > 35% at visit 1. Drug type & dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.

Secondary Outcome Measures

Duration of Heart Failure

The duration of Heart Failure was collected at Baseline (Visit 1).

Number of Patients With Current Use of Concomitant Compound

Use of concomitant compounds were collected at baseline (Visit 1)

Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2

Use of concomitant compounds were collected at 6 months (Visit 2)

Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics

For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.

Number of Patients With Different NT-proBNP Level Categories

NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, > 1200 pg/ml).

Percentages of Clinically Stable Patients

Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.

Number of Patients by Cardiologist Prescription Practice Per Country/Region

The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline.

Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline

At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline.

Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)

Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)

The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.

Number of Patients in Different Living Conditions

Living conditions were collected at Baseline (Visit 1).

Number of Patients in Different Employment Status

Employment status was collected at Baseline (Visit 1).

Number of Patients With Smoking Status

Smoking status was collected at baseline (visit 1).

Number of Patients From Different Geographical Regions

Geographic regions were collected at Baseline (Visit 1).

Number of Patients With Health Insurance Status

Health insurance status was collected at Baseline (Visit 1).

Number of Patients at Different Educational Level

Educational level was collected at Baseline (Visit 1).

Number of Patients Per Primary Etiology of Heart Failure

The primary etiology of Heart Failure was collected at Baseline (Visit 1).

Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study

HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.

Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities

Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)

Mean Dose of Previously Taken and Current Use of Concomitant Medications

Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline

Number of Heart Failure (HF) Treatment Combinations

The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).

Duration of Treatment With Device Type

The duration of treatment with device type was collected at baseline (Visit 1)

Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds

Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected

Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region

For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.

Full Information

NCT ID

NCT02807857

First Posted

June 17, 2016

Last Updated

February 2, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02807857

Brief Title

A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

Acronym

PREFER

Official Title

A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 7, 2016 (Actual)

Primary Completion Date

March 23, 2018 (Actual)

Study Completion Date

March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

Detailed Description

In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF < or = 40%) and NT-proBNP level > or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure (CHF)

Keywords

low-interventional observational study,, CHF,, heart failure,, primary care,, ESC guidelines,, Europe,, NT-proBNP,, reduced ventricular ejection fraction (EF),

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1415 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients' heart failure and non-heart failure

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Standard care

Intervention Description

Patients will receive the treatment that their primary care physician has decided to prescribe for their disease

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline (Visit 1)

Title

Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose

Description

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Duration of Heart Failure

Description

The duration of Heart Failure was collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients With Current Use of Concomitant Compound

Description

Use of concomitant compounds were collected at baseline (Visit 1)

Time Frame

Baseline (Visit 1)

Title

Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2

Description

Use of concomitant compounds were collected at 6 months (Visit 2)

Time Frame

6 months (Visit 2)

Title

Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics

Description

Time Frame

6 months

Title

Number of Patients With Different NT-proBNP Level Categories

Description

Time Frame

One measurement in all consecutive patients at baseline (Visit 1)

Title

Percentages of Clinically Stable Patients

Description

Time Frame

Baseline (Visit 1)

Title

Number of Patients by Cardiologist Prescription Practice Per Country/Region

Description

Time Frame

6 months

Title

Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline

Description

Time Frame

10 months

Title

Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)

Description

Time Frame

Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)

Title

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)

Description

Time Frame

Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)

Title

Number of Patients in Different Living Conditions

Description

Living conditions were collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients in Different Employment Status

Description

Employment status was collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients With Smoking Status

Description

Smoking status was collected at baseline (visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients From Different Geographical Regions

Description

Geographic regions were collected at Baseline (Visit 1).

Time Frame

Baseline (visit 1)

Title

Number of Patients With Health Insurance Status

Description

Health insurance status was collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients at Different Educational Level

Description

Educational level was collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients Per Primary Etiology of Heart Failure

Description

The primary etiology of Heart Failure was collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study

Description

HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.

Time Frame

Baseline (Visit 1), 6 months, 10 months

Title

Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities

Description

Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)

Time Frame

Baseline (Visit 1)

Title

Mean Dose of Previously Taken and Current Use of Concomitant Medications

Description

Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline

Time Frame

Baseline (Visit 1), 6 months, 10 months

Title

Number of Heart Failure (HF) Treatment Combinations

Description

The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).

Time Frame

Baseline (Visit 1)

Title

Duration of Treatment With Device Type

Description

The duration of treatment with device type was collected at baseline (Visit 1)

Time Frame

Baseline (Visit 1)

Title

Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds

Description

Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected

Time Frame

Baseline (Visit 1)

Title

Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region

Description

Time Frame

Baseline (Visit 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to provide written informed consent and accept study procedures and time schedule. Age ≥ 18 years. Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history). Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history. Exclusion Criteria: Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study. Cancer or other significant co-morbidities implying that the patient's condition is unstable. Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR < 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months. Patients who are primarily managed and regularly followed-up by a cardiologist for their HF Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.

Facility Information:

Facility Name

Novartis Investigative Site

City

Binkom

State/Province

BEL

ZIP/Postal Code

3211

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gozee

State/Province

BEL

ZIP/Postal Code

6534

Country

Belgium

Facility Name

Novartis Investigative Site

City

Linkebeek

State/Province

BEL

ZIP/Postal Code

1630

Country

Belgium

Facility Name

Novartis Investigative Site

City

Oostham

State/Province

BEL

ZIP/Postal Code

3945

Country

Belgium

Facility Name

Novartis Investigative Site

City

Zichem

State/Province

BEL

ZIP/Postal Code

3271

Country

Belgium

Facility Name

Novartis Investigative Site

City

Aarschot

ZIP/Postal Code

3200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Alveringem

ZIP/Postal Code

8691

Country

Belgium

Facility Name

Novartis Investigative Site

City

Boezinge

ZIP/Postal Code

8904

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxe

ZIP/Postal Code

1080

Country

Belgium

Facility Name

Novartis Investigative Site

City

Buggenhout, Belgium

ZIP/Postal Code

9255

Country

Belgium

Facility Name

Novartis Investigative Site

City

Deinze

ZIP/Postal Code

9800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Deurne

ZIP/Postal Code

2100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Diksmuide

ZIP/Postal Code

8600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ezemaal-Neerwinden

ZIP/Postal Code

3400

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt, Belgium

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Herzele

ZIP/Postal Code

9550

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kluisbergen

ZIP/Postal Code

9690

Country

Belgium

Facility Name

Novartis Investigative Site

City

Landen

ZIP/Postal Code

3400

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leefdaal

ZIP/Postal Code

3060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Linkebeek

ZIP/Postal Code

1630

Country

Belgium

Facility Name

Novartis Investigative Site

City

Lommel

ZIP/Postal Code

3920

Country

Belgium

Facility Name

Novartis Investigative Site

City

Maasmechelen

ZIP/Postal Code

3630

Country

Belgium

Facility Name

Novartis Investigative Site

City

Mont sur Marchienne

ZIP/Postal Code

6032

Country

Belgium

Facility Name

Novartis Investigative Site

City

Nazareth

ZIP/Postal Code

9810

Country

Belgium

Facility Name

Novartis Investigative Site

City

OOsteeklo

ZIP/Postal Code

9988

Country

Belgium

Facility Name

Novartis Investigative Site

City

Oostende

Country

Belgium

Facility Name

Novartis Investigative Site

City

Oudenaarde

ZIP/Postal Code

9700

Country

Belgium

Facility Name

Novartis Investigative Site

City

Saint-Medard

ZIP/Postal Code

6887

Country

Belgium

Facility Name

Novartis Investigative Site

City

Stoumont

ZIP/Postal Code

4987

Country

Belgium

Facility Name

Novartis Investigative Site

City

Tessenderlo

ZIP/Postal Code

3980

Country

Belgium

Facility Name

Novartis Investigative Site

City

Thuilles

ZIP/Postal Code

6536

Country

Belgium

Facility Name

Novartis Investigative Site

City

Tielt-Winge

ZIP/Postal Code

3390

Country

Belgium

Facility Name

Novartis Investigative Site

City

Tremelo

ZIP/Postal Code

3120

Country

Belgium

Facility Name

Novartis Investigative Site

City

Vilvoorde

ZIP/Postal Code

1800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Waregem

ZIP/Postal Code

8790

Country

Belgium

Facility Name

Novartis Investigative Site

City

Rijeka

State/Province

HRV

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Visnjevac

State/Province

HRV

ZIP/Postal Code

31220

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

State/Province

HRV

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Bizovac

ZIP/Postal Code

31222

Country

Croatia

Facility Name

Novartis Investigative Site

City

HRV

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

HRV

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novartis Investigative Site

City

HRV

ZIP/Postal Code

42000

Country

Croatia

Facility Name

Novartis Investigative Site

City

HRV

ZIP/Postal Code

44320

Country

Croatia

Facility Name

Novartis Investigative Site

City

Krasica

ZIP/Postal Code

51224

Country

Croatia

Facility Name

Novartis Investigative Site

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Slavonski Brod

ZIP/Postal Code

35000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Velika Kopanica

ZIP/Postal Code

35221

Country

Croatia

Facility Name

Novartis Investigative Site

City

Viskovo

ZIP/Postal Code

51216

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Nicosia

ZIP/Postal Code

2048

Country

Cyprus

Facility Name

Novartis Investigative Site

City

Nicosia

ZIP/Postal Code

2540

Country

Cyprus

Facility Name

Novartis Investigative Site

City

Præstø

ZIP/Postal Code

4720

Country

Denmark

Facility Name

Novartis Investigative Site

City

Skive

ZIP/Postal Code

7800

Country

Denmark

Facility Name

Novartis Investigative Site

City

Someru

State/Province

EST

ZIP/Postal Code

44201

Country

Estonia

Facility Name

Novartis Investigative Site

City

Paide

ZIP/Postal Code

72713

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

11911

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13415

Country

Estonia

Facility Name

Novartis Investigative Site

City

Arras

ZIP/Postal Code

62000

Country

France

Facility Name

Novartis Investigative Site

City

Bersee

ZIP/Postal Code

59254

Country

France

Facility Name

Novartis Investigative Site

City

Breteuil Sur Seine

ZIP/Postal Code

27160

Country

France

Facility Name

Novartis Investigative Site

City

Cannes

ZIP/Postal Code

06400

Country

France

Facility Name

Novartis Investigative Site

City

Chantepie

ZIP/Postal Code

35135

Country

France

Facility Name

Novartis Investigative Site

City

Colombiers

ZIP/Postal Code

31770

Country

France

Facility Name

Novartis Investigative Site

City

Coursan

ZIP/Postal Code

11110

Country

France

Facility Name

Novartis Investigative Site

City

Erquy

ZIP/Postal Code

22430

Country

France

Facility Name

Novartis Investigative Site

City

La Seyne-sur-Mer

ZIP/Postal Code

83500

Country

France

Facility Name

Novartis Investigative Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

Novartis Investigative Site

City

Les Pennes Mirabeau

ZIP/Postal Code

13170

Country

France

Facility Name

Novartis Investigative Site

City

Negrepelisse

ZIP/Postal Code

82800

Country

France

Facility Name

Novartis Investigative Site

City

Orthez

ZIP/Postal Code

64300

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Novartis Investigative Site

City

Rosiers d'Egleton

ZIP/Postal Code

19300

Country

France

Facility Name

Novartis Investigative Site

City

Salles

ZIP/Postal Code

33770

Country

France

Facility Name

Novartis Investigative Site

City

Six Fours

ZIP/Postal Code

83140

Country

France

Facility Name

Novartis Investigative Site

City

St orens de Gameville

ZIP/Postal Code

31650

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

Novartis Investigative Site

City

Balatonkeresztur

ZIP/Postal Code

8647

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

Novartis Investigative Site

City

Csongrad

ZIP/Postal Code

6640

Country

Hungary

Facility Name

Novartis Investigative Site

City

Erd

ZIP/Postal Code

2030

Country

Hungary

Facility Name

Novartis Investigative Site

City

Felsorajk

ZIP/Postal Code

8767

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hosszuheteny

ZIP/Postal Code

7694

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Korondi

ZIP/Postal Code

6726

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szabadsag

ZIP/Postal Code

6756

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged-Szoreg

ZIP/Postal Code

H-6771

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Zakanyszek

ZIP/Postal Code

6787

Country

Hungary

Facility Name

Novartis Investigative Site

City

Beer Sheva

ZIP/Postal Code

8477713

Country

Israel

Facility Name

Novartis Investigative Site

City

Grumello Del Monte

State/Province

ZIP/Postal Code

24064

Country

Italy

Facility Name

Novartis Investigative Site

City

Gatteo

State/Province

ZIP/Postal Code

47043

Country

Italy

Facility Name

Novartis Investigative Site

City

Jelgava

State/Province

LVA

ZIP/Postal Code

LV-3001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

LVA

ZIP/Postal Code

LV 1010

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1006

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1021

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 45488

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

State/Province

LTU

ZIP/Postal Code

92304

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Alytus

ZIP/Postal Code

LT-62386

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-49387

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

LT-49449

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Xaghra

State/Province

Gozo

ZIP/Postal Code

XRA 2405

Country

Malta

Facility Name

Novartis Investigative Site

City

Xewkija

State/Province

Gozo

ZIP/Postal Code

VCT 110

Country

Malta

Facility Name

Novartis Investigative Site

City

Rabat

Country

Malta

Facility Name

Novartis Investigative Site

City

Flisa

ZIP/Postal Code

2270

Country

Norway

Facility Name

Novartis Investigative Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Novartis Investigative Site

City

Honefoss

ZIP/Postal Code

3515

Country

Norway

Facility Name

Novartis Investigative Site

City

Kirkenær

ZIP/Postal Code

2260

Country

Norway

Facility Name

Novartis Investigative Site

City

Lierskogen

ZIP/Postal Code

N-3420

Country

Norway

Facility Name

Novartis Investigative Site

City

Loten

ZIP/Postal Code

2340

Country

Norway

Facility Name

Novartis Investigative Site

City

Lørenskog

ZIP/Postal Code

1473

Country

Norway

Facility Name

Novartis Investigative Site

City

Noetteroey

ZIP/Postal Code

3163

Country

Norway

Facility Name

Novartis Investigative Site

City

Ostereidet

ZIP/Postal Code

5993

Country

Norway

Facility Name

Novartis Investigative Site

City

Skien

ZIP/Postal Code

3734

Country

Norway

Facility Name

Novartis Investigative Site

City

Chelm

State/Province

POL

ZIP/Postal Code

22-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Kartuzy

State/Province

POL

ZIP/Postal Code

83-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

State/Province

POL

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-746

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-867

Country

Poland

Facility Name

Novartis Investigative Site

City

Bielawa

ZIP/Postal Code

58-260

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85-021

Country

Poland

Facility Name

Novartis Investigative Site

City

Dzierzoniow

ZIP/Postal Code

58-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-018

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30 415

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-664

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-061

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-094

Country

Poland

Facility Name

Novartis Investigative Site

City

Miasteczko Slaskie

ZIP/Postal Code

42-610

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61-388

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01-493

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01-887

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

03 185

Country

Poland

Facility Name

Novartis Investigative Site

City

Wielen

ZIP/Postal Code

64-730

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

54-703

Country

Poland

Facility Name

Novartis Investigative Site

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Seixal

State/Province

Bairro Novo

ZIP/Postal Code

2840 481

Country

Portugal

Facility Name

Novartis Investigative Site

City

Cantanhede

ZIP/Postal Code

3060 123

Country

Portugal

Facility Name

Novartis Investigative Site

City

Leca da Palmeira

ZIP/Postal Code

4450 586

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1200 375

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1250 210

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1800 192

Country

Portugal

Facility Name

Novartis Investigative Site

City

Oeiras

ZIP/Postal Code

2780 163

Country

Portugal

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121374

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127206

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.- Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa

ZIP/Postal Code

450000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Vladivostok

ZIP/Postal Code

690002

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150047

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ivancna Gorica

ZIP/Postal Code

1295

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Kranj

ZIP/Postal Code

4000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Pesnica pri Mariboru

ZIP/Postal Code

2211

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Slovenske Konjice

ZIP/Postal Code

3210

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Spodnji Duplek

ZIP/Postal Code

2241

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Vrhnika

ZIP/Postal Code

1360

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Zalec

ZIP/Postal Code

3310

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Cambre

State/Province

A Coruna

ZIP/Postal Code

15660

Country

Spain

Facility Name

Novartis Investigative Site

City

Porto do Son

State/Province

A Coruña

ZIP/Postal Code

15970

Country

Spain

Facility Name

Novartis Investigative Site

City

Petrer

State/Province

Alicante

ZIP/Postal Code

03610

Country

Spain

Facility Name

Novartis Investigative Site

City

El Parador De Las Hortichiuela

State/Province

Almeria

ZIP/Postal Code

04720

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33009

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33013

Country

Spain

Facility Name

Novartis Investigative Site

City

El canaveral

State/Province

Caceres

ZIP/Postal Code

10820

Country

Spain

Facility Name

Novartis Investigative Site

City

Puerto Real

State/Province

Cadiz

ZIP/Postal Code

11510

Country

Spain

Facility Name

Novartis Investigative Site

City

Burriana

State/Province

Castellon

ZIP/Postal Code

12530

Country

Spain

Facility Name

Novartis Investigative Site

City

Alcudia

State/Province

Islas Baleares

ZIP/Postal Code

07400

Country

Spain

Facility Name

Novartis Investigative Site

City

Telde

State/Province

Las Palmas De Gran Canaria

ZIP/Postal Code

35215

Country

Spain

Facility Name

Novartis Investigative Site

City

Parla

State/Province

Madrid

ZIP/Postal Code

28982

Country

Spain

Facility Name

Novartis Investigative Site

City

A Estrada

State/Province

Pontevedra

ZIP/Postal Code

36681

Country

Spain

Facility Name

Novartis Investigative Site

City

Monteporeiro

State/Province

Pontevedra

ZIP/Postal Code

36162

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

ZIP/Postal Code

03540

Country

Spain

Facility Name

Novartis Investigative Site

City

Coruna

ZIP/Postal Code

15007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28030

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28032

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Novartis Investigative Site

City

Panxon

ZIP/Postal Code

36340

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

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A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care (PREFER)

Chronic Heart Failure (CHF)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial