Evaluation of Heart Failure Treatment Guided by NTproBNP vs Clinical Symptoms and Signs Alone - Tabular View

Tracking Information

First Received Date ^ICMJE

October 19, 2006

Last Updated Date

March 4, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary variable is a composite endpoint of days alive, days out of hospital and symptoms [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary variable is a composite endpoint of days alive, days out of hospital and symptoms after 9 months

Change History

Complete list of historical versions of study NCT00391846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of deaths [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: Yes ]
Changes in NTproBNP over time amd related to NYHA class [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Changes in KCCQ (overall, symptom score subset, related to NTproBNP) [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Changes in HFstatus and vital signs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Number of SAEs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: No ]
Number of DAEs [ Time Frame: Assessed after 9 months of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Number of deaths, CV hospitalisations
Changes in NTproBNP over time amd related to NYHA class
Changes in KCCQ (overall, symptom score subset, related to NTproBNP)
Changes in HFstatus and vital signs
Number of SAEs
Number of DAEs

Descriptive Information

Brief Title ^ICMJE

Evaluation of Heart Failure Treatment Guided by NTproBNP vs Clinical Symptoms and Signs Alone

Official Title ^ICMJE

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 HF and Left Ventricular Systolic Dysfunction

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Heart Failure
Ventricular Dysfunction, Left

Intervention ^ICMJE

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: KCCQ Questionnaire

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

January 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00391846

Responsible Party

Björn Ericsson, MD, Director Medical Affairs, AZ Sweden, Medical Department, AstraZeneca

Study ID Numbers ^ICMJE

D2452L00010, EUDRACT No. 2006-001259-36, SIGNAL HF

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	AstraZeneca Sweden Medical Director, MD	AstraZeneca
Principal Investigator:	Hans Persson, MD, PhD	Danderyd Hospital, Sweden
Study Director:	Bjorn Eriksson, MD	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP