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Trial Information
Summary: CALL Study: A Study of the Influence of Dilatrend (Carvedilol) on Physical Fitness and Quality of Life in Patients With Heart FailureStatus: Completed Protocol Number: ML17139 Sponsor: Roche Pharma (Schweiz) AG Company Division: Pharmaceutical Official Scientific Title: Influence of carvedilol (Dilatrend) on physical fitness and quality of life: assessment by accelerometry (using Physilog) in patients with heart failure (CALL study) Brief Summary: This study will evaluate the efficacy and tolerability of Dilatrend in patients with heart failure. Patients will take part in an outpatient cardiovascular rehabilitation program to study the influence of Dilatrend on physical fitness and quality of life. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 8. Study Phase: IV Study Design / Study Details:
Study Type: Interventional
Condition: Heart Failure Intervention Type: Drug Intervention Name: carvedilol[Dilatrend] Primary Outcome: 1. Effect on left ventricular function (difference in proBNP concentrations) Key Secondary Outcomes: 1. Median change in fitness parameters (as assessed by accelerometry); quality of life assessments Inclusion Criteria:
Exclusion Criteria:
Gender: Males or Females Age Limits: Min: 18 Years Accepts Healthy Volunteers: No Trial Registration Date: 03/10/2006 Date Last Updated: 10/17/2008
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