Genetic Predictors of Outcome in HCM Patients - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00156429

Purpose

This is a retrospective review of the data available on patients and their family members with HCM and prospective follow-up of this cohort for clinical outcome and diagnostic studies. Genetic samples are being examined in this cohort to determine whether certain to determine whether certain beta-AR polymorphisms as well as other common genetic polymorphisms are associated with different morphological features, such as LVH in patients with HCM and whether these polymorphisms influence the clinical course and outcome in patients with HCM. For that purpose, we will build a database with clinical information including serial echocardiographic measurements for patients with HCM that have regular follow up and test them for beta-AR polymorphisms as well as other common genetic polymorphisms and other known cardiac-related polymorphisms that can potentially contribute to the morphologic differences seen in patients with HCM.

Condition
Hypertrophic Cardiomyopathy

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Genetic Predictors of Outcome in HCM Patients

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood sample for DNA analysis

Estimated Enrollment:	540
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2010

Detailed Description:

This is a retrospective review of the data available on patients and their family members with HCM and prospective follow-up of this cohort for clinical outcome and diagnostic studies. Genetic samples are being examined in this cohort to determine whether certain to determine whether certain beta-AR polymorphisms as well as other common genetic polymorphisms are associated with different morphological features, such as LVH in patients with HCM and whether these polymorphisms influence the clinical course and outcome in patients with HCM. For that purpose, we will build a database with clinical information including serial echocardiographic measurements for patients with HCM that have regular follow up and test them for beta-AR polymorphisms as well as other common genetic polymorphisms and other known cardiac-related polymorphisms that can potentially contribute to the morphologic differences seen in patients with HCM.

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

patients with HCM

Criteria

Inclusion Criteria:

18+ years of age
Diagnosed with HCM defined by the presence of left ventricular hypertrophy with minimal wall thickness >/= 15mm without the presence of hypertension or systemic disease that can account for the degree of hypertrophy.

Exclusion Criteria:

Hypertension present prior to the diagnosis of HCM
aortic stenosis with aortic valve area < 1cm2
known systemic disease that can cause LVH, such as infiltrative diseases
able and willing to provide informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156429

Contacts

Contact: Samir F Saba, MD	412-647-6272	sabas@upmc.edu
Contact: Raed Abdelhadi, MD	412-647-6272	abdelhadirh@upmc.edu

Locations

United States, Pennsylvania
UPMC Presbyterian Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Pamela M White, RN 412-647-2931 whitepm@upmc.edu
Principal Investigator: Samir F. Saba, MD
Principal Investigator: Raed Abdelhadi, MD
Sub-Investigator: David S. Schwartzman, MD
Sub-Investigator: Sandeep Jain, MD
Sub-Investigator: Raveen Bazaz, MD
Sub-Investigator: William Barrington, MD
Sub-Investigator: Susan Brode, MD
Sub-Investigator: Barry London, MD
Sub-Investigator: Dennis McNamara, MD
Sub-Investigator: Jan Nemec, MD
Sub-Investigator: Pamela M. White, RN, BSN
Sub-Investigator: Andrew Voigt, MD
Sub-Investigator: Evan Adelstein, MD
Sub-Investigator: Frank Schwender, MD

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Samir F. Saba, MD

University of Pittsburgh

More Information

Responsible Party:	UPMC ( Samir Saba/Director, Cardiac Electrophysiology )
Study ID Numbers:	0507025, 0507025
Study First Received:	September 8, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00156429
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

genetic testing

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy
Heart Diseases
Cardiomyopathy, Hypertrophic
Constriction, Pathologic

Aortic valve stenosis
Aortic Valve Stenosis
Cardiomyopathies
Heart Valve Diseases

Additional relevant MeSH terms:

Aortic Stenosis, Subvalvular
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009