Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart Association classes II and III congestive heart failure: a prospective, placebo-controlled, double-blind crossover trial

Arch Intern Med. 2004 Mar 8;164(5):514-20. doi: 10.1001/archinte.164.5.514.


Background: Erectile dysfunction (ED) is common in patients with congestive heart failure (CHF) and is often associated with symptoms of depression. Although sildenafil citrate, a phosphodiesterase 5 inhibitor, is effective in treating ED, its use is considered a relative contraindication in CHF. We hypothesized that sildenafil is a safe and effective treatment for ED in patients with New York Heart Association classes II and III CHF and that treatment of ED will improve symptoms of depression and enhance perceived of quality of life.

Methods: We studied 35 patients in a prospective, placebo-controlled, crossover trial for 12 weeks. Inclusion required a history of chronic ED and absence of ischemia (negative results from exercise stress test or nuclear perfusion scan) or nitrate use. The tolerability of sildenafil citrate was established by monitoring the ambulatory blood pressure for 4 hours after a single 50-mg dose. Improvement in ED, the primary end point, was assessed using the International Index of Erectile Function survey. The effect of improved erectile function on quality of life and mood was assessed using the Minnesota Living With Heart Failure Questionnaire, the Beck Depression Index, and the Center for Epidemiological Studies-Depression Scale.

Results: Sildenafil caused a mean +/- SEM asymptomatic decrease in blood pressure of 6 +/- 3 mm Hg, and no patient experienced symptomatic hypotension or other significant adverse effects. Sildenafil improved the International Index for Erectile Function (P<.001) and both sets of depression scores. The Living With Heart Failure Questionnaire index also improved with sildenafil (P =.02).

Conclusion: Sildenafil is a safe and effective treatment for ED in men with New York Heart Association classes II and III CHF and provides relief of depressive symptoms, explaining an improvement in the perception of quality of life.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Comorbidity
  • Cross-Over Studies
  • Depression / epidemiology
  • Double-Blind Method
  • Heart Failure / epidemiology*
  • Heart Failure / psychology*
  • Humans
  • Impotence, Vasculogenic / drug therapy*
  • Impotence, Vasculogenic / epidemiology*
  • Male
  • Middle Aged
  • Penile Erection / drug effects
  • Phosphodiesterase Inhibitors / pharmacology
  • Phosphodiesterase Inhibitors / therapeutic use
  • Piperazines / pharmacology
  • Piperazines / therapeutic use*
  • Prospective Studies
  • Purines
  • Quality of Life*
  • Sildenafil Citrate
  • Sulfones
  • Vasodilator Agents / pharmacology
  • Vasodilator Agents / therapeutic use*


  • Phosphodiesterase Inhibitors
  • Piperazines
  • Purines
  • Sulfones
  • Vasodilator Agents
  • Sildenafil Citrate