Evaluation of heart failure treatment guided by N-terminal pro b-type natriuretic peptide (NTproBNP) vs clinical symptoms and signs alone

Study identifier:D2452L00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

heart failure

Phase

Phase 4

Healthy volunteers

Study drug

Captopril, Enalapril, Lisinopril, Ramipril, Trandolapril, Bisoprolol, Carvedilol, Metoprolol succinate, Candesartan, Valsartan, Eplerenone, Spironolactone, Diuretics, HF treatment according to Swedish guidelines

Sex

All

Actual Enrollment

252

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Oct 2006

Primary Completion Date: 01 Jan 2009

Study Completion Date: 01 Jan 2009

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

UMEA, Sweden

Location

Research Site

UPPSALA, Sweden

Location

Research Site

VASTERAS, Sweden

Location

Research Site

ALVESTA, Sweden

Location

Research Site

ARVIKA, Sweden

Location

Research Site

BJUV, Sweden

Location

Research Site

BORENSBERG, Sweden

Location

Research Site

BROMMA, Sweden

Arms	Assigned Interventions
Other: Guided by NT-proBNP Treatment guided by clinical symptoms and signs + NTproBNP	-
Other: Not Guided by NT-proBNP Treatment guided by clinical symptoms and signs	-

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=304&filename=CSR-D2452L00010.pdf
Download
CSR-D2452L00010.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Sweden Clinical Study Information

+46 8 55326000

Investigators

Principal Investigator

AstraZeneca Sweden Medical Director

AstraZeneca

Evaluation of heart failure treatment guided by N-terminal pro b-type natriuretic peptide (NTproBNP) vs clinical symptoms and signs alone

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=304&filename=CSR-D2452L00010.pdf

CSR-D2452L00010.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator