Study of Sildenafil in Patient With Heart Failure.

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00309816

First Posted: April 3, 2006

Last Update Posted: April 3, 2006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Massachusetts General Hospital

Tracking Information

First Submitted Date ^ICMJE

March 30, 2006

First Posted Date ^ICMJE

April 3, 2006

Last Update Posted Date

April 3, 2006

Start Date ^ICMJE

December 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Sildenafil in Patient With Heart Failure.

Official Title ^ICMJE

Measurement of the Effect of Sildenafil Citrate (Viagra) on the Hemodynamics of Exercise Tolerance in Advanced Congestive Heart Failure.

Brief Summary

The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.

Detailed Description

Patients will undergo an exercise stress test. One dose of Sildenafil will then be given, followed by a one hour rest period. A repeat exercise stress test will then be repeated.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: sildenafil

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Estimated Completion Date

February 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18 - 75 Ejection fraction <35% Heart failure limited by fatigue and shortness of breath -

Exclusion Criteria:

Inability to exercise. Patients with shortness of breath while resting. Patient requiring intravenous medication. Patients taking the following medications: nitroglycerine pill/patch/paste, isordil and Imdur

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00309816

Other Study ID Numbers ^ICMJE

2001-p-001039

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marc J Semigran, MD

Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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