Status:
COMPLETED
PDE5-Inhibition With Sildenafil in Chronic Heart Failure
Lead Sponsor:
University of Milan
Conditions:
Heart Failure
Eligibility:
MALE
30-80 years
Phase:
PHASE3
Brief 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 en...
Detailed Description
In chronic heart failure (CHF), endothelial function (EF) deterioration and muscle underperfusion elicit ergoreflex exercise oversignaling, hyperventilation and breathlessness. PDE5 inhibition, by imp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00407446
Start Date
January 1 2004
End Date
February 1 2005
Last Update
December 14 2006
Active Locations (1)
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1
Marco Guazzi, MD, PhD University of Milano
Milan, Italy, 20141