NCT00407446

Brief Summary

To test the hypothesis that long-term PDE5-inhibition by overexpressing the nitric oxide pathway is beneficial in chronic heart failure patients. Double-blind and placebo-controlled trial. Primary end-points: quality of life and exercise performance

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 heart-failure

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3 heart-failure

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

January 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
Last Updated

December 14, 2006

Status Verified

December 1, 2006

First QC Date

December 1, 2006

Last Update Submit

December 12, 2006

Conditions

Heart Failure

Keywords

PDE5 inhibitionchronic heart failureendothelial functionexercise ventilation

Outcome Measures

Primary Outcomes (1)

  • Exercise performance, ventilation efficiency, symptoms

Secondary Outcomes (1)

  • quality of life

Interventions

sildenafilDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility criteria were: consent to participate in the study after detailed information about procedures, possible clinical benefits and risks; ability to complete a maximal exercise test; forced expiratory volume in 1 sec/forced vital capacity ratio\>70%; left ventricular ejection fraction  45%, determined by echocardiography.

You may not qualify if:

  • Patients were not recruited if they had systolic blood pressure \> 140 and \<110 mmHg, diabetes mellitus, therapy with nitrate preparations, history of sildenafil intolerance, significant lung or valvular diseases, neuromuscular disorders, exercise-induced myocardial ischemia, atrial fibrillation (6), claudication, peripheral vascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marco Guazzi, MD, PhD University of Milano

Milan, 20141, Italy

Location

Related Publications (1)

  • Katz SD, Parker JD, Glasser DB, Bank AJ, Sherman N, Wang H, Sweeney M. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and chronic heart failure. Am J Cardiol. 2005 Jan 1;95(1):36-42. doi: 10.1016/j.amjcard.2004.08.060.

    PMID: 15619391BACKGROUND

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

  • Marco Guazzi, MD

    University of Milano

    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

December 1, 2006

First Posted

December 5, 2006

Study Start

January 1, 2004

Study Completion

February 1, 2005

Last Updated

December 14, 2006

Record last verified: 2006-12

Locations

IT(1)