Pacemaker, ArtificialNCT03317964
Genetic Basis of Pacing-induced Cardiomyopathy
An observational study of Pacemaker, Artificial and Cardiomyopathies, run by The Guthrie Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Artificial, Cardiomyopathies
- What is being tested?
- Saliva sample
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 19 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen at Robert Packer Hospital, Sayre, PA
Who may be able to join
- Patients who have been assessed for cardiomyopathy
Who cannot join
- Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
DNA will be extracted from the saliva to test for changes in genes related to cardiomyopathy.
- Conditions
- Pacemaker, Artificial, Cardiomyopathies
- Being tested
- Saliva sample
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sampleOther
Extract sample of saliva only once
| Study group | Role | What they receive |
|---|---|---|
| Saliva - cardiomyopathy | Saliva sample for genetic testing from subjects who developed cardiomyopathy Receives: Other: Saliva sample | |
| Saliva - no cardiomyopathy | Saliva sample for genetic testing from subjects who do not have cariomyopathy Receives: Other: Saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with genotype frequency
Number of participants with genotype frequency based on genetic testing of saliva samples
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start16 Oct 2017
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pramod Deshmukh, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317964
- Sponsor's protocol ID
- 1706-34
- Status last verified
- Jun 2025
- First submitted
- 16 Oct 2017
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Pacing-Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03317964
- Acronym / sponsor ID
- 1706-34
- Conditions
- Pacemaker, Artificial, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DNA will be extracted from the saliva to test for changes in genes related to cardiomyopathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saliva - cardiomyopathy | – | Other: Saliva sampleSaliva sample for genetic testing from subjects who developed cardiomyopathy |
| Saliva - no cardiomyopathy | – | Other: Saliva sampleSaliva sample for genetic testing from subjects who do not have cariomyopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen at Robert Packer Hospital, Sayre, PA
Key inclusion criteria (1 listed)
- Patients who have been assessed for cardiomyopathy
Key exclusion criteria (1 listed)
- Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva sampleExtract sample of saliva only once | Other | Saliva - cardiomyopathy, Saliva - no cardiomyopathy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pramod Deshmukh, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker, Artificial and Cardiomyopathies, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with genotype frequency (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.