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Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure (CARVIVA-HF)
Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate \> 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.
Details
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 121 |
| Start date | 2009-09 |
| Completion | 2010-10 |
Conditions
- Heart Failure
Interventions
- ivabradine
- "Drug:Carvedilol" and "Drug:Ivabradine"
- Carvedilol
Primary outcomes
- Exercise Tolerance Assessed by 6 Minute Walking Test — 3 months
Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist. Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible. - Maximal Oxygen Consumption — 3 months
Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.
Countries
Italy