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Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Primary Purpose

Heart Failure, Ventricular Dysfunction, Left

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Captopril
Enalapril
Lisinopril
Ramipril
Trandolapril
Bisoprolol
Carvedilol
Metoprolol succinate
Candesartan
Valsartan
Eplerenone
Spironolactone
Diuretics
HF treatment according to Swedish guidelines
Blood samples
The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Ventricular Dysfunction, NTproBNP

Eligibility Criteria

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

Inclusion Criteria:

  • Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
  • New York Heart Association(NYHA) class II-IV,
  • NTproBNP males>800 ng/L, females >1000 ng/L

Exclusion Criteria:

  • Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
  • Mitral/aortic stenosis,
  • Patients already receiving optimal HF treatment,
  • Severe reduction of kidney function

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Guided by NT-proBNP

Not Guided by NT-proBNP

Arm Description

Treatment guided by clinical symptoms and signs + NTproBNP

Treatment guided by clinical symptoms and signs

Outcomes

Primary Outcome Measures

Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)
The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented

Secondary Outcome Measures

Number of CV Deaths
Number of deaths
Number of Days in Hospital for CV Reason
Each overnight stay is counted as one day. The lower the better
Changes in Heart Failure Symptoms
Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.
Changes in NT-proBNP Values Over Time in All Patients
The 95% confidential interval (CI) is given as measure of dispersion
Changes in Health-related Quality of Life
Change range -100 to 100. The higher the better.
Total Number of Titration Steps in Prescribed Heart Failure Treatment
Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.
Discontinuations
Number of patients discontinued due to adverse events'

Full Information

First Posted
October 19, 2006
Last Updated
June 18, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00391846
Brief Title
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
Official Title
A Randomised, Single Blind, Multicentre, 9-month, Phase IV Study, Comparing Treatment Guided by Clinical Symptoms and Signs and NT-proBNP vs Treatment Guided by Clinical Symptoms and Signs Alone, in Patients With Heart Failure (HF) and Left Ventricular Systolic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dysfunction, Left
Keywords
Heart Failure, Ventricular Dysfunction, NTproBNP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided by NT-proBNP
Arm Type
Other
Arm Description
Treatment guided by clinical symptoms and signs + NTproBNP
Arm Title
Not Guided by NT-proBNP
Arm Type
Other
Arm Description
Treatment guided by clinical symptoms and signs
Intervention Type
Drug
Intervention Name(s)
Captopril
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Type
Drug
Intervention Name(s)
Trandolapril
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Type
Drug
Intervention Name(s)
Metoprolol succinate
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Atacand
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Type
Drug
Intervention Name(s)
Diuretics
Intervention Type
Drug
Intervention Name(s)
HF treatment according to Swedish guidelines
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Intervention Type
Procedure
Intervention Name(s)
The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Primary Outcome Measure Information:
Title
Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)
Description
The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Number of CV Deaths
Description
Number of deaths
Time Frame
9 months
Title
Number of Days in Hospital for CV Reason
Description
Each overnight stay is counted as one day. The lower the better
Time Frame
9 months
Title
Changes in Heart Failure Symptoms
Description
Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.
Time Frame
9 months and baseline
Title
Changes in NT-proBNP Values Over Time in All Patients
Description
The 95% confidential interval (CI) is given as measure of dispersion
Time Frame
9 months and baseline
Title
Changes in Health-related Quality of Life
Description
Change range -100 to 100. The higher the better.
Time Frame
9 months and baseline
Title
Total Number of Titration Steps in Prescribed Heart Failure Treatment
Description
Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.
Time Frame
9 months
Title
Discontinuations
Description
Number of patients discontinued due to adverse events'
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction. New York Heart Association(NYHA) class II-IV, NTproBNP males>800 ng/L, females >1000 ng/L Exclusion Criteria: Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months, Mitral/aortic stenosis, Patients already receiving optimal HF treatment, Severe reduction of kidney function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Sweden Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Persson, MD, PhD
Organizational Affiliation
Danderyd Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bjorn Eriksson, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Alvesta
Country
Sweden
Facility Name
Research Site
City
Arvika
Country
Sweden
Facility Name
Research Site
City
Bjuv
Country
Sweden
Facility Name
Research Site
City
Borensberg
Country
Sweden
Facility Name
Research Site
City
Bromma
Country
Sweden
Facility Name
Research Site
City
Dalby
Country
Sweden
Facility Name
Research Site
City
Eskilstuna
Country
Sweden
Facility Name
Research Site
City
Gagnef
Country
Sweden
Facility Name
Research Site
City
Goeteborg
Country
Sweden
Facility Name
Research Site
City
Hisings Karra
Country
Sweden
Facility Name
Research Site
City
Huddinge
Country
Sweden
Facility Name
Research Site
City
Huskvarna
Country
Sweden
Facility Name
Research Site
City
Joenkoeping
Country
Sweden
Facility Name
Research Site
City
Kalmar
Country
Sweden
Facility Name
Research Site
City
Kungalv
Country
Sweden
Facility Name
Research Site
City
Lerum
Country
Sweden
Facility Name
Research Site
City
Lessebo
Country
Sweden
Facility Name
Research Site
City
Lidkoping
Country
Sweden
Facility Name
Research Site
City
Lilla Edet
Country
Sweden
Facility Name
Research Site
City
Linkoeping
Country
Sweden
Facility Name
Research Site
City
Ludvika
Country
Sweden
Facility Name
Research Site
City
Lyckeby
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Moheda
Country
Sweden
Facility Name
Research Site
City
Motala
Country
Sweden
Facility Name
Research Site
City
Orebro
Country
Sweden
Facility Name
Research Site
City
Ostersund
Country
Sweden
Facility Name
Research Site
City
Skanor
Country
Sweden
Facility Name
Research Site
City
Soderakra
Country
Sweden
Facility Name
Research Site
City
Stenungsund
Country
Sweden
Facility Name
Research Site
City
Stocksund
Country
Sweden
Facility Name
Research Site
City
Timra
Country
Sweden
Facility Name
Research Site
City
Uddevalla
Country
Sweden
Facility Name
Research Site
City
Ulricehamn
Country
Sweden
Facility Name
Research Site
City
Umea
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Vasteras
Country
Sweden
Facility Name
Research Site
City
Vastervik
Country
Sweden
Facility Name
Research Site
City
Vaxjo
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

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