NCT00391846|CompletedPhase 4Results

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

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

AstraZeneca ClinicalTrials.gov

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3 other identifiers

D2452L00010EUDRACT No. 2006-001259-36SIGNAL HF

Study Type

interventional

Target

252

Locations

1 country

Sites

Timeline

RegisteredOct 2006

StartedOct 2006

CompletionJan 2009

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

252

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline

Completed

Started Oct 2006

Geographic Reach

1 country

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

October 1, 2006

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

June 18, 2012

Completed

Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

October 19, 2006

Results QC Date

May 10, 2010

Last Update Submit

June 18, 2012

Conditions

Heart Failure Ventricular Dysfunction, Left

Keywords

Heart FailureVentricular DysfunctionNTproBNP

Outcome Measures

Primary Outcomes (1)

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
9 months

Secondary Outcomes (7)

Number of CV Deaths
9 months
Number of Days in Hospital for CV Reason
9 months
Changes in Heart Failure Symptoms
9 months and baseline
Changes in NT-proBNP Values Over Time in All Patients
9 months and baseline
Changes in Health-related Quality of Life
9 months and baseline
+2 more secondary outcomes

Study Arms (2)

Guided by NT-proBNP

OTHER

Treatment guided by clinical symptoms and signs + NTproBNP

Drug: CaptoprilDrug: EnalaprilDrug: LisinoprilDrug: RamiprilDrug: TrandolaprilDrug: BisoprololDrug: CarvedilolDrug: Metoprolol succinateDrug: CandesartanDrug: ValsartanDrug: EplerenoneDrug: SpironolactoneDrug: DiureticsDrug: HF treatment according to Swedish guidelinesProcedure: Blood samplesProcedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Not Guided by NT-proBNP

OTHER

Treatment guided by clinical symptoms and signs