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

June 18, 2012 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alvesta, Sweden
        • Research Site
      • Arvika, Sweden
        • Research Site
      • Bjuv, Sweden
        • Research Site
      • Borensberg, Sweden
        • Research Site
      • Bromma, Sweden
        • Research Site
      • Dalby, Sweden
        • Research Site
      • Eskilstuna, Sweden
        • Research Site
      • Gagnef, Sweden
        • Research Site
      • Goeteborg, Sweden
        • Research Site
      • Hisings Karra, Sweden
        • Research Site
      • Huddinge, Sweden
        • Research Site
      • Huskvarna, Sweden
        • Research Site
      • Joenkoeping, Sweden
        • Research Site
      • Kalmar, Sweden
        • Research Site
      • Kungalv, Sweden
        • Research Site
      • Lerum, Sweden
        • Research Site
      • Lessebo, Sweden
        • Research Site
      • Lidkoping, Sweden
        • Research Site
      • Lilla Edet, Sweden
        • Research Site
      • Linkoeping, Sweden
        • Research Site
      • Ludvika, Sweden
        • Research Site
      • Lyckeby, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Moheda, Sweden
        • Research Site
      • Motala, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Ostersund, Sweden
        • Research Site
      • Skanor, Sweden
        • Research Site
      • Soderakra, Sweden
        • Research Site
      • Stenungsund, Sweden
        • Research Site
      • Stocksund, Sweden
        • Research Site
      • Timra, Sweden
        • Research Site
      • Uddevalla, Sweden
        • Research Site
      • Ulricehamn, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Vasteras, Sweden
        • Research Site
      • Vastervik, Sweden
        • Research Site
      • Vaxjo, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 23, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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