Study of Sildenafil in Advanced Heart Failure.

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00309790
First received: March 30, 2006
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Drug: sildenafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2003
Study Completion Date: March 2006
Detailed Description:

This study will compare two groups of patients. One group will receive sildenafil and the other group will receive a placebo (a pill which looks like sildenafil, but contains no medication).

Patients will undergo a heart catheterization, echocardiogram and exercise stress test. Patients will then take study medication for 12 weeks. A repeat heart catheterization, echocardiogram and exercise stress test will then be performed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309790

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Marc J Semigran, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc J Semigran, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00309790     History of Changes
Other Study ID Numbers: 2003-p-0003994
Study First Received: March 30, 2006
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
exercise stress test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 21, 2014