NCT00309816

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

April 3, 2006

Status Verified

March 1, 2006

First QC Date

March 30, 2006

Last Update Submit

March 30, 2006

Conditions

Congestive Heart Failure

Keywords

Exercise stress test

Outcome Measures

Primary Outcomes (1)

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

Interventions

sildenafilDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marc J Semigran, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 3, 2006

Study Start

December 1, 2001

Study Completion

February 1, 2006

Last Updated

April 3, 2006

Record last verified: 2006-03

Locations

US(1)