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 because the information has not been verified recently.

Verified October 2008 by Oslo University Hospital. Recruitment status was Recruiting

First Received on October 14, 2008. No Changes Posted

Sponsor:	Oslo University Hospital
Collaborators:	Norwegian Foundation for Health and Rehabilitation Pfizer
Information provided by:	Oslo University Hospital
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:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
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 Oslo University Hospital:

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

Oslo University Hospital

Norwegian Foundation for Health and Rehabilitation

Pfizer

More Information

No publications provided

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
Study First Received:	October 14, 2008
Last Updated:	October 14, 2008
Health Authority:	Norway: The National Committees for Research Ethics in Norway

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
Hypertension, Pulmonary
Heart Defects, Congenital
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

Phosphodiesterase Inhibitors
Sildenafil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012