Genetic Basis of Pacing-induced Cardiomyopathy

Genetic Basis of Pacing-Induced Cardiomyopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathies; Pacemaker, Artificial
• Intervention / Treatment: Other: Saliva sample

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Kamie Hoey, RN; Phone Number: 570-887-6070; Email: Kamie.Hoey@guthrie.org

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Recruiting
      • Robert Packer Hospital
      • Contact: Pramod Deshmukh, MD; Phone Number: 570-887-6070

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Robert Packer Hospital, Sayre, PA

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with genotype frequency	Number of participants with genotype frequency based on genetic testing of saliva samples	through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 1706-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No