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Genetic Predictors of Outcome in HCM Patients

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ClinicalTrials.gov Identifier: NCT00156429
Recruitment Status : Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Wong, University of Pittsburgh

Brief Summary:
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 or disease
Hypertrophic Cardiomyopathy

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.

Study Type : Observational
Estimated Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Predictors of Outcome in HCM Patients
Study Start Date : July 2005
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020





Primary Outcome Measures :
  1. Genetic testing [ Time Frame: Day 1 at the time of enrollment ]
    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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156429


Locations
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Samir F. Saba, MD University of Pittsburgh

Responsible Party: Timothy Wong, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00156429     History of Changes
Other Study ID Numbers: 0507025
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Timothy Wong, University of Pittsburgh:
genetic testing

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