Genetic Predictors of Outcome in HCM Patients | NCT00156429

Studies
Genetic Predictors of Outcome in HCM Patients

NCT00156429

Sponsor

University of Pittsburgh

Status

Terminated

Last Update Posted

Aug 4, 2020Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Hypertrophic Cardiomyopathy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0507025

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Preliminary analyses did not reveal significant associations.

Expanded Access Info

Start Date

Apr 22, 2009Actual

Primary Completion Date

Jul 30, 2020Actual

Completion Date

Jul 30, 2020Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2020

Last Update Posted Date

Aug 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Wong, Assistant Professor, University of PittsburghPrincipal Investigator

Lead Sponsor

University of PittsburghOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

98Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic testing	AR polymorphisms will be correlated to progression of LVH and clinical outcome in patients with HCM.	Day 1 at the time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with HCM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samir F. Saba, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Presbyterian Hospital		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular

Browse Leaves

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Browse Branches

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