Phase 3
Completed N=121
Heart Rate Reduction in Heart Failure
Source: ClinicalTrials.gov NCT01178528 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Exercise Tolerance Assessed by 6 Minute Walking Test — 474.8; 435.7; 453.1 meters
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Tolerance Assessed by 6 Minute Walking Test |
474.8; 435.7; 453.1 | — |
| PRIMARY Maximal Oxygen Consumption |
15.8; 12.9; 14.7 | — |
| SECONDARY Quality of Life |
6.7; 4.1; 6.1 | — |
| SECONDARY New York Heart Association (NYHA) Class |
30; 5; 20 | — |
Eligibility Criteria
Inclusion Criteria
- heart failure II-III
- ischemic origin
- stable medications from at least 3 months
- > 3 months from an acute ischemic syndrome or revascularization procedure
- naive on heart rate reducing agents
Exclusion Criteria
- bradycardia
- hypersensitivity or contraindications to study drugs
- exercise tolerance at 6 minute walking test 400 m
Data sourced from ClinicalTrials.gov (NCT01178528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.