Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure

• Status: Unknown status
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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"). Sildenafil is a medication that is used to treat high blood pressure in the lungs and may reduce symptoms of heart failure. Studies have looked at the short-term benefit of sildenafil in patients with congestive heart failure, but this study will look at the longer-term benefits of 12 weeks of therapy with sildenafil.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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