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Efficacy and Outcome with Felodipine in Heart failure - VHEFT-III
Description:
Felodipine vs. placebo in congestive heart failure
Hypothesis:
Felodipine when added to standard therapy for congestive heart failure including digoxin, diuretic and vasodilators (angiotensin converting enzyme inhibitors) would decrease mortality and be safely tolerated.
Study Design
Study Design:
Female: 0
Primary Endpoints:
Not detailed
Secondary Endpoints:
Not detailed
Drug/Procedures Used:
Felodipine
Principal Findings:
Felodipine significantly reduced blood pressure and, at 3 months, increased ejection fraction but did not improve exercise tolerance, quality of life, or the need for hospitalization.
During long-term follow-up, favorable effects on ejection fraction and atrial peptide did not persist, but felodipine prevented worsening exercise tolerance and quality of life.
All cause mortality no different between groups (13.8% felodipine, 12.8% placebo).
Felodipine appeared well tolerated.
Interpretation:
These results suggest that outcome with regard to mortality were almost identical for Felodipine and placebo. The study had insufficient statistical power to detect a lack of adverse mortality effect. The drug appears to be safe but not clearly efficacious in patients with heart failure.
References:
1. Am J Cardiol 1996;77:1078-82. Rationale and design
2. Circulation 1997;96:856-63. Final results
Keywords: Exercise Tolerance, Felodipine, Follow-Up Studies, Digoxin, Diuretics, Blood Pressure, Vasodilator Agents, Calcium Channel Blockers, Oligopeptides, Quality of Life, Heart Failure
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