PDE5-Inhibition With Sildenafil in Chronic Heart Failure

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide pathway is beneficial in chronic heart failure patients.

Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise performance

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Eligibility criteria were: consent to participate in the study after detailed information about procedures, possible clinical benefits and risks; ability to complete a maximal exercise test; forced expiratory volume in 1 sec/forced vital capacity ratio>70%; left ventricular ejection fraction  45%, determined by echocardiography.

Exclusion Criteria:

• Patients were not recruited if they had systolic blood pressure > 140 and <110 mmHg, diabetes mellitus, therapy with nitrate preparations, history of sildenafil intolerance, significant lung or valvular diseases, neuromuscular disorders, exercise-induced myocardial ischemia, atrial fibrillation (6), claudication, peripheral vascular disease.