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Eisenmenger's Syndrome in Adults With CHD
This study is ongoing, but not recruiting participants.
First Received: December 19, 2005   Last Updated: May 22, 2007   History of Changes
Sponsored by: Children's Healthcare of Atlanta
Information provided by: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00266903
  Purpose

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.


Condition
Congenital Disorders

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title: Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 70
Study Start Date: January 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266903

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Wendy M. Book, MD Emory University SOM
  More Information

No publications provided

Study ID Numbers: 05-118
Study First Received: December 19, 2005
Last Updated: May 22, 2007
ClinicalTrials.gov Identifier: NCT00266903     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
adult
congenital heart disease
Eisenmenger's Syndrome
Bosentan
Sitaxsetan
Sildenafil

Study placed in the following topic categories:
Eisenmenger Complex
Vasodilator Agents
Eisenmenger Syndrome
Heart Diseases
Cardiovascular Abnormalities
Sildenafil
Congenital Abnormalities
Heart Defects, Congenital
Bosentan

Additional relevant MeSH terms:
Eisenmenger Complex
Pathologic Processes
Disease
Heart Diseases
Cardiovascular Abnormalities
Syndrome
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on May 07, 2009