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Reversibility by Sildenafil of Exercise-Induced Abnormal Right Ventricular Pressure Response in ASD and VSD-Operated Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772135
First Posted: October 15, 2008
Last Update Posted: October 15, 2008
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.
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Pfizer
Information provided by:
Oslo University Hospital
  Purpose
The purpose of this study is to determine whether oral sildenafil citrate reduces the abnormal right ventricular pressure response during exercise in adolescent and adult patients with specific types of congenital heart defects.

Condition Intervention
Congenital Heart Disease Drug: sildenafil citrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Pulmonary Hypertension in Adolescents and Adults With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Right ventricular pressure as measured by max velocity of tricuspid valve regurgitation [ Time Frame: baseline and max exercise ]

Secondary Outcome Measures:
  • DLco (lung diffusion test) [ Time Frame: baseline and max exercise ]
  • cardiac output [ Time Frame: baseline and max exercise ]

Estimated Enrollment: 15
Study Start Date: September 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sildenafil citrate
    capsule of 50 mg , 90 minutes before exercise study
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exercise right ventricular systolic pressure of 45 mm Hg or above.
  • Operated for atrial septal defect or ventricular septal defect or minimal defect not operated or minimal residual defect.

Exclusion Criteria:

  • Acute infectious/febrile illness,
  • Significant mental or physical disability preventing reliable exercise testing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772135


Contacts
Contact: Erik Thaulow, professor Dr Med +47 23074537 erik.thaulow@rikshospitalet.no
Contact: Henrik Holmstrom, dr med +47 23074541 henrik.holmstrom@rikshospitalet.no

Locations
Norway
Rikshospitalet University Hospital Recruiting
Oslo, Norway, 0027
Contact: Henrik Brun, MD    +4723074554    henrik.brun@rikshospitalet.no   
Contact: per morten fredriksen, dr scient    +4723072277    per.morten.fredriksen@rikshospitalet.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian Foundation for Health and Rehabilitation
Pfizer
  More Information

Responsible Party: Steinar Johansen, Foreningen for Hjertesyke Barn
ClinicalTrials.gov Identifier: NCT00772135     History of Changes
Other Study ID Numbers: RH 2008 HR 2006 / 2 / 0012 TM
2006 / 2 / 0012
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by Oslo University Hospital:
pulmonary hypertension
congenital heart defects
exercise
phosphodiesterase inhibitors
Exercise induced pulmonary arterial hypertensive response in congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Hypertension, Pulmonary
Heart Defects, Congenital
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents