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Fosinopril Efficacy/Safety Trial - FEST
Description:
Fosinopril for symptoms and clinical outcome in mild-to-moderate CHF.
Hypothesis:
To determine the effect of fosinopril on symptoms and clinical outcome in mild-to-moderate CHF.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 308
Mean Follow Up: 12 weeks
Patient Populations:
18-75 years of age
NYHA class II or III heart failure
Primary Endpoints:
Exercise tolerance
Secondary Endpoints:
Clinical deterioration, need for hospitalization
Drug/Procedures Used:
Fosinopril 10 mg qd titrated to 20 mg qd over 4 weeks, then to target dose of 40 mg qd as tolerated.
Concomitant Medications:
Diuretics, digoxin, nitrates
Principal Findings:
A total of 155 patients were randomized to receive fosinopril; 153 patients were randomized to placebo. Most fosinopril patients (87.1%) reached the target dose of 40 mg qd. Twenty-eight patients in the fosinopril group and 35 patients in the placebo group did not complete the study protocol.
At 12 weeks, patients randomized to fosinopril had larger increases in bicycle exercise time than patients receiving placebo (38.1 sec vs 23.5 s).
Patients receiving fosinopril remained free of clinical deterioration significantly better than patients receiving placebo. Significant differences were noted in symptomatic relief (dyspnea, fatigue, NYHA class.) Hospitalizations were significantly less frequent for patients receiving fosinopril therapy (3% vs 12%, p= 0.002).
Interpretation:
ACE inhibition improved symptoms and need for hospitalization among patients with mild to moderate heart failure. The study was not powered to detect a mortality difference between the two groups. The results are consistent with the larger SOLVD and CONSENSUS trials of ACE inhibition for CHF.
References:
1. Eur Heart J 1995;16:1892-9.
Keywords: Fosinopril, Heart Failure, Dyspnea, Consensus
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