Skip to main content
OpenTrials
Completed

NCT Number: NCT00266903

Eisenmenger's Syndrome in Adults With CHD

Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Disorders Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eisenmenger Complex Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

The primary objective of this study is to examine medical records of patients with Eisenmenger's Syndrome in order to determine the effect of endothelin receptor antagonists, alone or in combination, with Sildenafil, on symptoms of pulmonary hypertension. This review will be conducted on Standard of Care procedures such as New York Heart Association (NYHA) classification, six-minute walk exercise capacity, pulmonary pressures and oxygens saturations. Pulmonary pressures determined by echo or cardiac catheterization will be analyzed where available. We hypothesize that patients with congenital heart defects who develop ES will have an improved six-minute walk distance, improved pulmonary arterial pressures and improved oxygenation after treatment with endothelin receptor antagonists and other pulmonary vasodilators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80

Exclusion criteria

  • Those who do not meet inclusion criteria

Treatment and study plan

Primary outcomes

  1. Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart disease

    Time frame: 12 years

    Our study demonstrates that endothelin receptor blockers can be used to improve exercise tolerance, oxygenation, and functional status in adults with Eisenmenger syndrome without adverse effects. The role of newer treatment modalities such as prostacyclins, PDE inhibitors, and nitric oxide remain promising and their role needs to be investigated to help improve quality of life and life expectancy in these patients.

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Registry information

Official study title

Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators

Important dates

Study start
1996
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2005
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.