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Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE) (HIDE)

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

NYHA assessment

Serum NT-proBNP concentration

Transthoracic Ecocardiogram

About this trial

This is an interventional screening trial for Heart Failure focused on measuring Heart failure, Cardiovascular risk factors, NT-proBNP, NYHA assessment

Eligibility Criteria

61 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Male or female patients aged > 60 years at the time of informed consent
Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart):
1. Hypertension
2. Dyslipidemia
3. Obesity
4. Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
5. Type 1 or 2 diabetes mellitus
6. Chronic kidney disease
7. Arrhythmia requiring therapy
8. Moderate to severe valvular disease
9. History of alcohol abuse,
10. History of smoking,
11. History of cancer chemotherapy, or
i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray
Attendance at a primary care consultation for reasons not related to HF

Exclusion Criteria:

Previous diagnosis of HF
Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
Echocardiogram performed within the 12 months before the primary care consultation

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects with CV risk factors

Arm Description

Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.

Outcomes

Primary Outcome Measures

Number of Cases of HF stage C

Proportion of subjects with HF Stage C among those with 2 or more CV risk factors

Secondary Outcome Measures

Comparison of number of subjects diagnosed with HF stage C

Comparison of the number of subjects diagnosed with l HF Stage C versus the time matched historical proportion at the same study sites

Percentage of subjects with CV risk factos

Percentage of subjects with each listed CV risk factor among those with HF Stage C

Percentage of subjects with CV risk factors among participating countries

Percentage of subjects with each listed CV risk factor among participating countries

Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C

Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF

Incidence of equality of HF Stage C among participating countries

Proportion and equality of proportions of HF Stage C subjects among participating countries

Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF

Comparison of the mean NT-proBNP (≥ 125 pg/mL) levels among subjects diagnosed with overall HF Stage C versus subjects with no HF

Full Information

NCT ID

NCT04143919

First Posted

October 28, 2019

Last Updated

March 17, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04143919

Brief Title

Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

Acronym

HIDE

Official Title

Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 31, 2020 (Actual)

Primary Completion Date

June 7, 2021 (Actual)

Study Completion Date

June 11, 2021 (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 is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3 countries in Central America.

Detailed Description

Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject will be referred to a country specific central echocardiography laboratory for a transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and relevant structural heart disease.

6. Conditions and Keywords

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

Heart Failure

Keywords

Heart failure, Cardiovascular risk factors, NT-proBNP, NYHA assessment

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A recent Cochrane analysis reported a high burden of HF in Latin America (Ciapponi et al 2016), reporting an incidence of HF of 199 cases per 100 000 person-years. A cross-sectional study of 633 individuals aged ≥ 45 years, randomly selected and registered in a primary care program in Brazil (Jorge et al 2016) reported 36.6% of patients with Stage A HF, 42.7% with Stage B, and and 9.3% with symptomatic HF (Stage C). In real world settings primary care physician may attend to up to 40 patients per day, which rose to as many as 70 patients per day during high season demand, meaning in some circunstances physicians may only have up to 12 minutes per patient so patients with HF may go unnoticed. The aim of this study is to assess the practicality of an algorithm to identify new cases of HF Stage C in subjects who are at risk of CV disease in real world high-volume ambulatory primary care settings in Central America.

Masking

None (Open Label)

Allocation

N/A

Enrollment

317 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with CV risk factors

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

NYHA assessment

Intervention Description

The New York Heart Association (NYHA) functional classification of HF

Intervention Type

Procedure

Intervention Name(s)

Serum NT-proBNP concentration

Intervention Description

Subjects with NYHA score ≥ II will undergo a rapid, on site serum NT-proBNP test on the same day of the visit. Roche CARDIAC proBNP+ test, using the Cobas h 232 device, is a quantitative immunological test for the determination of NT-proBNP in heparinized venous blood.

Intervention Type

Diagnostic Test

Intervention Name(s)

Transthoracic Ecocardiogram

Intervention Description

Subjects with a serum NT-proBNP result of ≥ 125 pg/mL at Visit 1 will be referred to a study cardiologist for a transthoracic echocardiogram to assess LVEF and relevant structural heart disease

Primary Outcome Measure Information:

Title

Number of Cases of HF stage C

Description

Proportion of subjects with HF Stage C among those with 2 or more CV risk factors

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Comparison of number of subjects diagnosed with HF stage C

Description

Comparison of the number of subjects diagnosed with l HF Stage C versus the time matched historical proportion at the same study sites

Time Frame

5 months

Title

Percentage of subjects with CV risk factos

Description

Percentage of subjects with each listed CV risk factor among those with HF Stage C

Time Frame

5 months

Title

Percentage of subjects with CV risk factors among participating countries

Description

Percentage of subjects with each listed CV risk factor among participating countries

Time Frame

5 months

Title

Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C

Description

Ratio of presence versus absence of each listed CV risk factor between subjects with overall HF Stage C and without HF

Time Frame

5 months

Title

Incidence of equality of HF Stage C among participating countries

Description

Proportion and equality of proportions of HF Stage C subjects among participating countries

Time Frame

5 months

Title

Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF

Description

Comparison of the mean NT-proBNP (≥ 125 pg/mL) levels among subjects diagnosed with overall HF Stage C versus subjects with no HF

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

61 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study Male or female patients aged > 60 years at the time of informed consent Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart): Hypertension Dyslipidemia Obesity Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease Type 1 or 2 diabetes mellitus Chronic kidney disease Arrhythmia requiring therapy Moderate to severe valvular disease History of alcohol abuse, History of smoking, History of cancer chemotherapy, or i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray Attendance at a primary care consultation for reasons not related to HF Exclusion Criteria: Previous diagnosis of HF Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months) Echocardiogram performed within the 12 months before the primary care consultation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceutical

Organizational Affiliation

Novartis Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Santo Domingo

ZIP/Postal Code

10203

Country

Dominican Republic

Facility Name

Novartis Investigative Site

City

Santo Domingo

Country

Dominican Republic

Facility Name

Novartis Investigative Site

City

San Salvador

ZIP/Postal Code

1101

Country

El Salvador

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01009

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala city

ZIP/Postal Code

01010

Country

Guatemala

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

Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

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