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

Phase 4

Completed

• Conditions: Heart Failure; Ventricular Dysfunction, Left
• Interventions: Drug: Captopril; Drug: Enalapril; Drug: Lisinopril; Drug: Ramipril; Drug: Trandolapril; Drug: Bisoprolol; Drug: Carvedilol; Drug: Metoprolol succinate; Drug: Candesartan; Drug: Valsartan; Drug: Eplerenone; Drug: Spironolactone; Drug: Diuretics; Drug: HF treatment according to Swedish guidelines; Procedure: Blood samples; Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

• Registration Number: NCT00391846
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-25
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-05-10
• Results First Submitted QC: 2012-05-15
• Status Verified: 2012-06
• Results First Posted: 2012-06-18
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided by NT-proBNP	Metoprolol succinate	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Diuretics	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	HF treatment according to Swedish guidelines	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Blood samples	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	The Kansas City Cardiomyopathy Questionnaire (KCCQ)	Treatment guided by clinical symptoms and signs + NTproBNP
Not Guided by NT-proBNP	Ramipril	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Diuretics	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	HF treatment according to Swedish guidelines	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Blood samples	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Metoprolol succinate	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	The Kansas City Cardiomyopathy Questionnaire (KCCQ)	Treatment guided by clinical symptoms and signs
Guided by NT-proBNP	Captopril	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Spironolactone	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Enalapril	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Lisinopril	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Trandolapril	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Ramipril	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Bisoprolol	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Carvedilol	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Candesartan	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Eplerenone	Treatment guided by clinical symptoms and signs + NTproBNP
Guided by NT-proBNP	Valsartan	Treatment guided by clinical symptoms and signs + NTproBNP
Not Guided by NT-proBNP	Captopril	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Enalapril	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Trandolapril	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Lisinopril	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Bisoprolol	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Candesartan	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Carvedilol	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Valsartan	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Eplerenone	Treatment guided by clinical symptoms and signs
Not Guided by NT-proBNP	Spironolactone	Treatment guided by clinical symptoms and signs

Primary Outcome Measures

Name	Time	Method
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)	9 months	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

Name	Time	Method
Number of CV Deaths	9 months	Number of deaths
Number of Days in Hospital for CV Reason	9 months	Each overnight stay is counted as one day. The lower the better
Changes in Heart Failure Symptoms	9 months and baseline	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	9 months and baseline	The 95% confidential interval (CI) is given as measure of dispersion
Changes in Health-related Quality of Life	9 months and baseline	Change range -100 to 100. The higher the better.
Total Number of Titration Steps in Prescribed Heart Failure Treatment	9 months	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	9 months	Number of patients discontinued due to adverse events'

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vaxjo, Sweden