Genetic Basis of Pacing-induced Cardiomyopathy

Sponsor
The Guthrie Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03317964
Collaborator
(none)
170
1
74.5
2.3

Study Details

Study Description

Brief Summary

The purpose of this study is to collect a saliva sample from patients with a pacemaker to study genes involved in cardiomyopathy, a condition where the heart muscle is abnormal.

Condition or Disease Intervention/Treatment Phase
  • Other: Saliva sample

Detailed Description

DNA will be extracted from the saliva to test for changes in genes related to cardiomyopathy.

Study Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Genetic Basis of Pacing-Induced Cardiomyopathy
Actual Study Start Date :
Oct 16, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Saliva - cardiomyopathy

Saliva sample for genetic testing from subjects who developed cardiomyopathy

Other: Saliva sample
Extract sample of saliva only once

Saliva - no cardiomyopathy

Saliva sample for genetic testing from subjects who do not have cariomyopathy

Other: Saliva sample
Extract sample of saliva only once

Outcome Measures

Primary Outcome Measures

  1. Number of participants with genotype frequency [through study completion, an average of 1 year]

    Number of participants with genotype frequency based on genetic testing of saliva samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have been assessed for cardiomyopathy
Exclusion Criteria:
  • Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Packer Hospital Sayre Pennsylvania United States 18840

Sponsors and Collaborators

  • The Guthrie Clinic

Investigators

  • Principal Investigator: Pramod Deshmukh, MD, The Guthrie Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Guthrie Clinic
ClinicalTrials.gov Identifier:
NCT03317964
Other Study ID Numbers:
  • 1706-34
First Posted:
Oct 23, 2017
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022