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Eisenmenger's Syndrome in Adults With CHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00266903
First received: December 19, 2005
Last updated: March 14, 2012
Last verified: May 2007
  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

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators

Resource links provided by NLM:


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
Sampling Method:   Non-Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00266903     History of Changes
Other Study ID Numbers: 05-118
Study First Received: December 19, 2005
Last Updated: March 14, 2012
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

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

ClinicalTrials.gov processed this record on November 19, 2014