Chronic Sildenafil Treatment in Heart Failure

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

In heart failure (HF), a defective nitric oxide (NO) signaling may be involved in left ventricular (LV) diastolic abnormalities and LV remodelling progression. PDE5-inhibition, by blocking NO degradation and overexpressing cellular cyclic guanosine monophosphate (cGMP) pathways might be beneficial. Several short term studies have demonstrated safety and clinical improvement in stable heart failure (HF) patients.

The purpose of this study is to test the effects on LV diastolic function, cardiac geometry and clinical status in a cohort of HF patients.

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

Details

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

Criteria

Inclusion Criteria:

• consent to participate in the study after detailed information about procedures, possible clinical benefits and risks;

• negative exercise stress test prior to study initiation;

• forced expiratory volume in 1 sec/forced vital capacity ratio>70%;

• left ventricular ejection fraction < 45%, determined by echocardiography.

Exclusion Criteria:

• subjects unable to complete a maximal exercise test

• systolic blood pressure > 140 and <110 mmHg

• diabetes mellitus

• therapy with nitrate preparations

• history of sildenafil intolerance

• significant lung or valvular diseases

• neuromuscular disorders, claudication

• peripheral vascular disease