NCT03317964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

7.7 years

First QC Date

October 16, 2017

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Saliva - cardiomyopathy

Saliva sample for genetic testing from subjects who developed cardiomyopathy

Other: Saliva sample

Saliva - no cardiomyopathy

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

Other: Saliva sample

Interventions

Extract sample of saliva only once

Saliva - cardiomyopathySaliva - no cardiomyopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen at Robert Packer Hospital, Sayre, PA

You may qualify if:

  • Patients who have been assessed for cardiomyopathy

You may not qualify if:

  • Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pramod Deshmukh, MD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 23, 2017

Study Start

October 16, 2017

Primary Completion

June 19, 2025

Study Completion

June 19, 2025

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations