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

September 8, 2005
June 17, 2013
July 2005
May 2020   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00156429 on ClinicalTrials.gov Archive Site
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Genetic Predictors of Outcome in HCM Patients
Genetic Predictors of Outcome in HCM Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood sample for DNA analysis

Non-Probability Sample

patients with HCM

Hypertrophic Cardiomyopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
May 2020
May 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Samir F Saba, MD 412-647-6272 sabas@upmc.edu
United States
 
NCT00156429
0507025, 0507025
No
Samir Saba, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Samir F. Saba, MD University of Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP