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Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients

NCT00586794 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-06-06

No results posted yet for this study

Summary

Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level. The combination of critically increased pulmonary vascular resistance, progressive pressure load of the right ventricle and disturbance of pulmonary gas exchange result in long-term polymorbidity. The objective of this study is to provide evidence of improvement of patients exercise tolerance as well as general conditions by treatment with oral sildenafil as a specific pulmonary vasodilator.

Conditions

  • Pulmonary Arterial Hypertension (PAH)

Interventions

DRUG

Sildenafil

3x per day 20 mg TID

DRUG

Placebo

3x per day, 20 mg TID

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Competence Network for Congenital Heart Defects

    lead OTHER_GOV

Principal Investigators

  • Siegrun Mebus, MD · German Heart Institute Munich, Competence Network for Congenital Heart Defects

  • Ingram Schulze-Neick, MD · Great Ormond Street Hospital for Sick Children,London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00586794 on ClinicalTrials.gov