Trial information
CALL Study: A Study of the Influence of Dilatrend (Carvedilol) on Physical Fitness and Quality of Life in Patients With Heart Failure
Status: 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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- adult patients >18 years of age;
- heart failure of any etiology;
- no established treatment with beta-blockers.
Exclusion criteria:
- planned coronary bypass surgery or coronary angioplasty in the next 12 weeks;
- contraindication to introduction of a beta-blocker.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Switzerland
