Status:
WITHDRAWN
Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure
Lead Sponsor:
University of New Mexico
Conditions:
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate whether sildenafil helps treat heart failure. Some patients with heart failure have high blood pressure in the lungs (referred to as "pulmonary hypertension"). ...
Detailed Description
Objective: To determine the effect of acute and long-term treatment with sildenafil on the clinical status of patients with moderate HF. Secondary Objectives: To determine the effect of acute and long...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Diagnosis of chronic heart failure with an ejection fraction less than or equal to 45% per either an echocardiogram, nuclear cardiolyte stress test, or cardiac catheterization performed within the past 6 months.
- New York Heart Association Functional Class III
- Must be on optimal heart failure therapy according to AHA/ACC heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment
Exclusion
- Comorbid disease or behavioral or other limitations that: 1) interfere with performing exercise test, or 2) prevent completion of 12 week study
- Currently pregnant or intent to become pregnant in the next 12 weeks or currently breastfeeding.
- Major cardiovascular event or cardiovascular procedure within the prior 6 weeks
- History of Chronic Obstructive Pulmonary Disease or Reactive Airway Disease
- Known hypersensitivity to sildenafil
- Current use of medications known to be a potent inhibitor of CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole)
- Current or recent (within 6 months) use of organic nitrate medications (e.g. isosorbide dinitrate, sublingual nitroglycerin)
- Known diagnosis of pulmonary veno-occlusive disease or non-arteritic anterior ischemic optic neuropathy
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00793338
Start Date
November 1 2008
End Date
February 1 2011
Last Update
June 26 2023
Active Locations (1)
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1
Clinical Translational Science Center
Albuquerque, New Mexico, United States, 87131