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

This study is currently recruiting participants.

Verified by Rikshospitalet HF, October 2008

First Received: October 14, 2008 No Changes Posted

Sponsor:	Rikshospitalet HF
Collaborators:	Norwegian Foundation for Health and Rehabilitation Pfizer
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00772135

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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Pulmonary Hypertension in Adolescents and Adults With Congenital Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Congenital Heart Defects Exercise and Physical Fitness Heart Diseases High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

Right ventricular pressure as measured by max velocity of tricuspid valve regurgitation [ Time Frame: baseline and max exercise ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DLco (lung diffusion test) [ Time Frame: baseline and max exercise ] [ Designated as safety issue: No ]
cardiac output [ Time Frame: baseline and max exercise ] [ Designated as safety issue: No ]

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:

capsule of 50 mg , 90 minutes before exercise study

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 25 Years
Genders Eligible for Study:	Both
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

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

Rikshospitalet HF

Norwegian Foundation for Health and Rehabilitation

Pfizer

More Information

No publications provided

Responsible Party:	Foreningen for Hjertesyke Barn ( Steinar Johansen )
Study ID Numbers:	RH 2008 HR 2006 / 2 / 0012 TM, 2006 / 2 / 0012
Study First Received:	October 14, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00772135 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet HF:

pulmonary hypertension
congenital heart defects
exercise
phosphodiesterase inhibitors
Exercise induced pulmonary arterial hypertensive response in congenital heart disease

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Cardiovascular Abnormalities
Molecular Mechanisms of Pharmacological Action
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on November 25, 2009