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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Ventricular Dysfunction, Left; Heart Failure

Treatments: Drug: Captopril; Drug: Valsartan; Drug: Bisoprolol; Drug: Carvedilol; Drug: Spironolactone; Drug: Trandolapril; Drug: HF treatment according to Swedish guidelines; Drug: Ramipril; Procedure: Blood samples; Drug: Enalapril; Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ); Drug: Diuretics; Drug: Candesartan; Drug: Eplerenone; Drug: Lisinopril; Drug: Metoprolol succinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391846

SIGNAL HF

D2452L00010

EUDRACT No. 2006-001259-36

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Guided by NT-proBNP

Other group

Description:

Treatment guided by clinical symptoms and signs + NTproBNP

Treatment:

Drug: Captopril

Drug: Carvedilol

Drug: Candesartan

Drug: Spironolactone

Drug: Valsartan

Drug: Trandolapril

Drug: Ramipril

Drug: Bisoprolol

Drug: Eplerenone

Drug: Metoprolol succinate

Drug: Lisinopril

Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Drug: Diuretics

Procedure: Blood samples

Drug: HF treatment according to Swedish guidelines

Drug: Enalapril

Not Guided by NT-proBNP

Other group

Description:

Treatment guided by clinical symptoms and signs

Treatment:

Drug: Captopril

Drug: Carvedilol

Drug: Candesartan

Drug: Spironolactone

Drug: Valsartan

Drug: Trandolapril

Drug: Ramipril

Drug: Bisoprolol

Drug: Eplerenone

Drug: Metoprolol succinate

Drug: Lisinopril

Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Drug: Diuretics

Procedure: Blood samples

Drug: HF treatment according to Swedish guidelines

Drug: Enalapril