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Genetic Predictors of Outcome in HCM Patients

This study is currently recruiting participants.
Verified June 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00156429
First received: September 8, 2005
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Genetic testing [ Time Frame: Day 1 at the time of enrollment ] [ Designated as safety issue: No ]
    AR polymorphisms will be correlated to progression of LVH and clinical outcome in patients with HCM.


Biospecimen Retention:   Samples With DNA

Blood sample for DNA analysis


Estimated Enrollment: 540
Study Start Date: July 2005
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
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

Locations
United States, Pennsylvania
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly A Veltre, MSN     412-864-1420     veltrek@upmc.edu    
Principal Investigator: Samir F. Saba, 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: Dennis McNamara, MD            
Sub-Investigator: Jan Nemec, MD            
Sub-Investigator: Andrew Voigt, MD            
Sub-Investigator: Evan Adelstein, MD            
Sub-Investigator: Ferhaan Ahmad, MD,            
Sub-Investigator: Norman Wang, MD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Samir F. Saba, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Samir Saba, Director, Cardiac Electrophysiology, UPMC, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00156429     History of Changes
Other Study ID Numbers: 0507025, 0507025
Study First Received: September 8, 2005
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
genetic testing

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013