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Clinical Trials/NCT00772135
NCT00772135UnknownNot Applicable

Pulmonary Hypertension in Adolescents and Adults With Congenital Heart Disease

Oslo University Hospital2 sites in 1 country15 target enrollmentStarted: September 1, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
15
Locations
2
Primary Endpoint
Right ventricular pressure as measured by max velocity of tricuspid valve regurgitation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

13.3 Study design and protocol

13.3.1 Design: double-blind case-control cross-over study

13.3.2 Patients inclusion / exclusion criteria:

The study consists of 12-16 patients from the main study (see main protocol) who are selected by following criteria

  • Abnormal right ventricular pressure response to exercise (cut-off 45 mmHg maximal RVSP during exercise)
  • Informed consent to participation including use of sildenafil / placebo. The patients will be approximately one year older than during the initial study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
16 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Right ventricular pressure as measured by max velocity of tricuspid valve regurgitation

Time Frame: baseline and max exercise

Secondary Outcomes

  • DLco (lung diffusion test)(baseline and max exercise)
  • cardiac output(baseline and max exercise)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other

Study Sites (2)

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