Status:
COMPLETED
Chronic Sildenafil Treatment in Heart Failure
Lead Sponsor:
University of Milan
Conditions:
Heart Failure
Eligibility:
MALE
38-80 years
Phase:
PHASE3
Brief 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 degradat...
Detailed Description
Heart failure (HF) is a significant health care concern that is evolving to epidemic proportions. Development of new forms of interventions remains a challenging task. An abnormal nitric oxide (NO) pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00975494
Start Date
April 1 2005
End Date
December 1 2008
Last Update
September 11 2009
Active Locations (2)
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1
University of Milano
Milan, Italy, 20142
2
University of Milano
Milan, Italy