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Genetic Basis of Pacing-induced Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03317964
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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
Pacemaker, Artificial Cardiomyopathies Other: Saliva sample

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic Basis of Pacing-Induced Cardiomyopathy
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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




Primary Outcome Measures :
  1. Number of participants with genotype frequency [ Time Frame: through study completion, an average of 1 year ]
    Number of participants with genotype frequency based on genetic testing of saliva samples


Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at Robert Packer Hospital, Sayre, PA
Criteria

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

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): NCT03317964


Contacts
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Contact: Kamie Hoey, RN 570-887-6070 Kamie.Hoey@guthrie.org

Locations
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United States, Pennsylvania
Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Pramod Deshmukh, MD    570-887-6070      
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Pramod Deshmukh, MD The Guthrie Clinic

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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT03317964     History of Changes
Other Study ID Numbers: 1706-34
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases