Study of Sildenafil in Advanced Heart Failure.

NCT00309790 | Completed Phase 3

• 1 other identifier: 2003-p-0003994
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite advances in medical therapy for patients with heart failure, one-third of patients remain limited by fatigue and shortness of breath. Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in heart pressure and exercise capacity. Currently sildenafil is not FDA approved for the treatment of heart failure. The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure.

Conditions

Congestive Heart Failure

Keywords

exercise stress test

Outcome Measures

Primary Outcomes (2)

• Patients will have the following performed at baseline and again after taking study medication for 12 weeks: exercise capacity measured by exercise stress test, heart pressure measured by a heart catheterization and

• quality of life measured by questionnaires at baseline and at 12 weeks

Interventions

sildenafil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years Ejection fraction \<40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension

You may not qualify if:

• Patients taking the following medications: nitroglycerine pill/patch/paste, isordil, Imdur, antifungal agents and certain antidepressants.
• Patients with a history of optic neuropathy or unexplained visual impairment. Patients with anemia.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (3)

• Malhotra R, Dhakal BP, Eisman AS, Pappagianopoulos PP, Dress A, Weiner RB, Baggish AL, Semigran MJ, Lewis GD. Pulmonary Vascular Distensibility Predicts Pulmonary Hypertension Severity, Exercise Capacity, and Survival in Heart Failure. Circ Heart Fail. 2016 Jun;9(6):10.1161/CIRCHEARTFAILURE.115.003011 e003011. doi: 10.1161/CIRCHEARTFAILURE.115.003011.

  PMID: 27301469 DERIVED

• Murphy RM, Shah RV, Malhotra R, Pappagianopoulos PP, Hough SS, Systrom DM, Semigran MJ, Lewis GD. Exercise oscillatory ventilation in systolic heart failure: an indicator of impaired hemodynamic response to exercise. Circulation. 2011 Sep 27;124(13):1442-51. doi: 10.1161/CIRCULATIONAHA.111.024141. Epub 2011 Aug 29.

  PMID: 21875912 DERIVED

• Lewis GD, Murphy RM, Shah RV, Pappagianopoulos PP, Malhotra R, Bloch KD, Systrom DM, Semigran MJ. Pulmonary vascular response patterns during exercise in left ventricular systolic dysfunction predict exercise capacity and outcomes. Circ Heart Fail. 2011 May;4(3):276-85. doi: 10.1161/CIRCHEARTFAILURE.110.959437. Epub 2011 Feb 3.

  PMID: 21292991 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marc J Semigran, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: April 3, 2006
• Study Start: May 1, 2003
• Study Completion: March 1, 2006
• Last Updated: August 11, 2009

Record last verified: 2009-08