Atrial FibrillationNCT05190679
Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a prospective, case-control study that seeks to learn about the role of genetics in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how the investigators treat atrial fibrillation. The study will enroll 225 participants. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- None/Observational Studies
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 3 Mar 2026
- How long will I take part?
- 6 Weeks
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: Previous participants who were enrolled in the Vanderbilt Atrial Fibrillation Registry (IVR#020669), Atrial Fibrillation Ablation Registry (IRB#110881), or Early-onset Atrial Fibrillation Registry (IRB#201666).
Who may be able to join
- Minors >15 years
- Adult > 18 years
- Able to provide written informed consent
- Previously enrolled in the Vanderbilt Atrial Fibrillation Registry (IVR#020669)
- Atrial Fibrillation Ablation Registry (IRB#110881)
- Early-onset Atrial Fibrillation Registry (IRB#201666)
- Underwent whole genome sequencing/whole exome sequencing or clinical genetic testing and based on those results meets the genetic criteria for cases and controls as defined as a Cardiomyopathy (CM) Rare Variant (P/LP rare variant in CM gene, Arrhythmia Rare Variant (P/LP rare variant in arrhythmia gene), or a Control (no rare variant in CM, arrhythmia, or other Atrial Fibrillation gene).
- Diagnosis of Atrial Fibrillation prior to age of 65 (</=65)
Who cannot join
- -Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This is a prospective, case-control study that seeks to learn about the role of genetics in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how the investigators treat atrial fibrillation. The study will enroll 225 participants. Eligible participants will have undergone sequencing for arrhythmia and cardiomyopathy (CM) genes. Based on those results, participants will be recruited for an outpatient research visit with testing that includes cardiac MRI, rest/stress/signal-averaged ECGs, and cardiac monitoring. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended.
Read the detailed description
This study will address the hypothesis that re-phenotyping patients with AF and pathogenic arrhythmia/CM variants will identify unrecognized underlying genetic disease.
The investigators will recruit from participants sequenced as part of our prospective clinical registries and participants cared for in the Vanderbilt Genetic Arrhythmia Clinic or Meharry Arrhythmia Clinic and enrolled in the Vanderbilt Early-onset Atrial Fibrillation Registry (IRB #201666). Eligible participants will have pathogenic/likely pathogenic (P/LP) rare variants (or matched controls) and will undergo prospective cardiac phenotyping, which will include a cardiac MRI, rest/stress/signal averaged ECGs, blood work, and ambulatory ECG monitoring. A subset of patients will also undergo a procainamide drug challenge. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended.
This study will define the cardiac phenotype of individuals with AF who have a P/LP rare variant in an inherited arrhythmia or CM disease gene and compare to controls. Participants with a P/LP variant in a cardiomyopathy gene or arrhythmia gene (N=150) will be compared to controls (N=75). Controls will have no P/LP variant and be balanced for sex, race, and ethnicity. The association between P/LP variants and the following endpoints will be tested: 1) imaging and ECG-derived measurements (e.g., ventricular size, function, fibrosis, ectopy); 2) diagnoses (e.g., arrhythmogenic cardiomyopathy (AC), hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), Long QT Syndrome (LQTS), Short QT Syndrome (SQTS), Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), Progressive Cardiac Conduction Disease (PCCD); and 3) management changes including new medical therapy, activity restrictions, implantable cardioverter-defibrillator use, or cascade screening. Sample sizes per group have been selected to power the diagnostic and management endpoints. An Adjudication Committee with arrhythmia, CM, and genetics expertise will determine if diagnostic criteria are met and make management recommendations.
- Conditions
- Atrial Fibrillation
- Being tested
- None/Observational Studies
- Keywords
- Genetic disease
- Medical subject headings
- Atrial Fibrillation, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None/Observational StudiesOther
This is an observational study and there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cardiomyopathy Rare Variant Cases | Identified Pathogenic/Likely pathogenic rare variant in cardiomyopathy (CM) gene which include inherited CM syndromes. Receives: Other: None/Observational Studies | |
| Arrhythmia Rare Variant Cases | Identified Pathogenic/Likely pathogenic rare variant in arrhythmia genes. Receives: Other: None/Observational Studies | |
| Controls | No rare variant in CM, arrhythmia, or other atrial fibrillation gene. Receives: Other: None/Observational Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Inherited Cardiomyopathy (CM) Syndromes.
Clinical data and results are reviewed by the Adjudication Committee to determine if criteria for diagnostic endpoints are met for each participant that has completed the phenotyping protocol. The committee will remain blinded to the participant's genotype until the discussion of the clinical phenotyping result has ended. Genetic test results will be revealed and final determination of the diagnosis will be made. The Adjudication Committee will use published diagnostic criteria for specific inherited CM syndromes: Arrhythmogenic cardiomyopathy (AC), Arrhythmogenic Right Ventricular CM (ARVC), Dilated CM (DCM), Hypertrophic CM (HCM), and Left Ventricular Noncompaction CM (LVNC). For AC and DCM, only participants determined to have "definite" AC or DCM according to the diagnostic criteria will be considered as meeting the primary diagnostic endpoint.
Measured: 6 weeks
Number of Participants with Inherited Arrhythmia Syndromes.
The primary diagnostic endpoint will be determined by the Adjudication Committee using the published criteria for Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), Long QT Syndrome (LQTS), Progressive Cardiac Conduction Disease (PCCD), and Short QT Syndrome (SQTS) from the 2013 HRS/EHRA/APHRS Expert Consensus Statement on the Management of Inherited Arrhythmias.
Measured: 6 weeks
Number of Participants with Adverse Structural and Electrophysiologic Changes to the Atria and Ventricles for Inherited Cardiomyopathy Syndromes.
Quantitative imaging and ECG metrics will compare participants who have a pathogenic or likely pathogenic (P/LP) rare variants linked to a CM disease gene compared to controls. Imaging and ECG metrics will be used to assess adverse structural and electrophysiologic changes to the atria and ventricles from inherited cardiomyopathy syndromes. Quantitative metrics will be assessed from contrast-enhanced MRI, signal-averaged ECG, resting 12- lead ECG, Stress treadmill ECG, and ambulatory ECG monitor. Results will be used to test the hypothesis that cases have increased measures of proarrhythmic structural and electrophysiologic changes compared to controls by imaging and ECG endpoints.
Measured: 6 weeks
Number of Participants with Adverse Structural and Electrophysiologic Changes to the Atria and Ventricles for Inherited Arrhythmia Syndromes.
Quantitative imaging and ECG metrics will compare participants who have a P/LP rare variants linked to an inherited arrhythmia disease gene and will compare to controls. Imaging and ECG metrics will be used to assess adverse structural and electrophysiologic changes to the atria and ventricles from inherited arrhythmia syndromes. Quantitative metrics will be assessed from resting 12- lead ECG, Stress treadmill ECG, and ambulatory ECG monitor. A procainamide challenge will be used on select participants with a non-diagnostic (type II or III) Brugada pattern identified on their previous resting 12-lead ECG or who are P/LP variant carriers in an identified Brugada susceptibility gene. Results will be used to test the hypothesis that cases have increased measures of proarrhythmic structural and electrophysiologic changes compared to controls by imaging and ECG endpoints.
Measured: 6 Weeks
Number of Participants with Changes in Management of Inherited Arrhythmia and CM Syndromes.
The Adjudication Committee will determine the management recommendations for each participant at the time of case review. The primary analysis will focus on changes in each management category (e.g., medical therapy, physical activity restrictions, stroke prophylaxis, implantable cardioverter-defibrillator utilization) that resulted from discovery of a rare variant, and a secondary analysis will compare the management in each category regardless of whether it was pre-existing or newly initiated. The participant will be contacted, the results will be reviewed by the principal investigator or coinvestigators to discuss the results of the testing. Any recommendations regarding clinical care will be communicated to the participants existing physicians and ensure adequate follow-up is arranged or will assist the participant in establishing care with a qualified physician.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start27 Apr 2022
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 155 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, James L. Laws, Vanderbilt University Medical Center
- Investigators
- M. B Shoemaker, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190679
- Sponsor's protocol ID
- 210819
- Other IDs
- R01HL155197
- Status last verified
- Apr 2026
- First submitted
- 28 Dec 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shoemaker MB, Shah RL, Roden DM, Perez MV. How Will Genetics Inform the Clinical Care of Atrial Fibrillation? Circ Res. 2020 Jun 19;127(1):111-127. doi: 10.1161/CIRCRESAHA.120.316365. Epub 2020 Jun 18.
PubMed 32716712Yoneda ZT, Anderson KC, Quintana JA, O'Neill MJ, Sims RA, Glazer AM, Shaffer CM, Crawford DM, Stricker T, Ye F, Wells Q, Stevenson LW, Michaud GF, Darbar D, Lubitz SA, Ellinor PT, Roden DM, Shoemaker MB. Early-Onset Atrial Fibrillation and the Prevalence of Rare Variants in Cardiomyopathy and Arrhythmia Genes. JAMA Cardiol. 2021 Dec 1;6(12):1371-1379. doi: 10.1001/jamacardio.2021.3370.
PubMed 34495297
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05190679
- Acronym / sponsor ID
- 210819
- Conditions
- Atrial Fibrillation
- Keywords
- Genetic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 13 Jan 2022 (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.
This is a prospective, case-control study that seeks to learn about the role of genetics in early onset atrial fibrillation (AF) and if genetic testing can be used to improve how the investigators treat atrial fibrillation. The study will enroll 225 participants. Eligible participants will have undergone sequencing for arrhythmia and cardiomyopathy (CM) genes. Based on those results, participants will be recruited for an outpatient research visit with testing that includes cardiac MRI, rest/stress/signal-averaged ECGs, and cardiac monitoring. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended.
Detailed description
This study will address the hypothesis that re-phenotyping patients with AF and pathogenic arrhythmia/CM variants will identify unrecognized underlying genetic disease.
The investigators will recruit from participants sequenced as part of our prospective clinical registries and participants cared for in the Vanderbilt Genetic Arrhythmia Clinic or Meharry Arrhythmia Clinic and enrolled in the Vanderbilt Early-onset Atrial Fibrillation Registry (IRB #201666). Eligible participants will have pathogenic/likely pathogenic (P/LP) rare variants (or matched controls) and will undergo prospective cardiac phenotyping, which will include a cardiac MRI, rest/stress/signal averaged ECGs, blood work, and ambulatory ECG monitoring. A subset of patients will also undergo a procainamide drug challenge. If an inherited arrhythmia/CM syndrome is diagnosed, guideline-directed changes to medical care will be recommended.
This study will define the cardiac phenotype of individuals with AF who have a P/LP rare variant in an inherited arrhythmia or CM disease gene and compare to controls. Participants with a P/LP variant in a cardiomyopathy gene or arrhythmia gene (N=150) will be compared to controls (N=75). Controls will have no P/LP variant and be balanced for sex, race, and ethnicity. The association between P/LP variants and the following endpoints will be tested: 1) imaging and ECG-derived measurements (e.g., ventricular size, function, fibrosis, ectopy); 2) diagnoses (e.g., arrhythmogenic cardiomyopathy (AC), hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), Long QT Syndrome (LQTS), Short QT Syndrome (SQTS), Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), Progressive Cardiac Conduction Disease (PCCD); and 3) management changes including new medical therapy, activity restrictions, implantable cardioverter-defibrillator use, or cascade screening. Sample sizes per group have been selected to power the diagnostic and management endpoints. An Adjudication Committee with arrhythmia, CM, and genetics expertise will determine if diagnostic criteria are met and make management recommendations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiomyopathy Rare Variant Cases | – | Other: None/Observational StudiesIdentified Pathogenic/Likely pathogenic rare variant in cardiomyopathy (CM) gene which include inherited CM syndromes. |
| Arrhythmia Rare Variant Cases | – | Other: None/Observational StudiesIdentified Pathogenic/Likely pathogenic rare variant in arrhythmia genes. |
| Controls | – | Other: None/Observational StudiesNo rare variant in CM, arrhythmia, or other atrial fibrillation gene. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Previous participants who were enrolled in the Vanderbilt Atrial Fibrillation Registry (IVR#020669), Atrial Fibrillation Ablation Registry (IRB#110881), or Early-onset Atrial Fibrillation Registry (IRB#201666).
Key inclusion criteria (8 listed)
- Minors >15 years
- Adult > 18 years
- Able to provide written informed consent
- Previously enrolled in the Vanderbilt Atrial Fibrillation Registry (IVR#020669)
- Atrial Fibrillation Ablation Registry (IRB#110881)
Key exclusion criteria (1 listed)
- -Pregnant women
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 |
|---|---|---|
| None/Observational StudiesThis is an observational study and there is no intervention. | Other | Arrhythmia Rare Variant Cases, Cardiomyopathy Rare Variant Cases, Controls |
Primary outcome
Number of Participants with Inherited Cardiomyopathy (CM) Syndromes.
Time frame: 6 weeks
Clinical data and results are reviewed by the Adjudication Committee to determine if criteria for diagnostic endpoints are met for each participant that has completed the phenotyping protocol. The committee will remain blinded to the participant's genotype until the discussion of the clinical phenotyping result has ended. Genetic test results will be revealed and final determination of the diagnosis will be made. The Adjudication Committee will use published diagnostic criteria for specific inherited CM syndromes: Arrhythmogenic cardiomyopathy (AC), Arrhythmogenic Right Ventricular CM (ARVC), Dilated CM (DCM), Hypertrophic CM (HCM), and Left Ventricular Noncompaction CM (LVNC). For AC and DCM, only participants determined to have "definite" AC or DCM according to the diagnostic criteria will be considered as meeting the primary diagnostic endpoint.
Number of Participants with Inherited Arrhythmia Syndromes.
Time frame: 6 weeks
The primary diagnostic endpoint will be determined by the Adjudication Committee using the published criteria for Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), Long QT Syndrome (LQTS), Progressive Cardiac Conduction Disease (PCCD), and Short QT Syndrome (SQTS) from the 2013 HRS/EHRA/APHRS Expert Consensus Statement on the Management of Inherited Arrhythmias.
Number of Participants with Adverse Structural and Electrophysiologic Changes to the Atria and Ventricles for Inherited Cardiomyopathy Syndromes.
Time frame: 6 weeks
Quantitative imaging and ECG metrics will compare participants who have a pathogenic or likely pathogenic (P/LP) rare variants linked to a CM disease gene compared to controls. Imaging and ECG metrics will be used to assess adverse structural and electrophysiologic changes to the atria and ventricles from inherited cardiomyopathy syndromes. Quantitative metrics will be assessed from contrast-enhanced MRI, signal-averaged ECG, resting 12- lead ECG, Stress treadmill ECG, and ambulatory ECG monitor. Results will be used to test the hypothesis that cases have increased measures of proarrhythmic structural and electrophysiologic changes compared to controls by imaging and ECG endpoints.
Number of Participants with Adverse Structural and Electrophysiologic Changes to the Atria and Ventricles for Inherited Arrhythmia Syndromes.
Time frame: 6 Weeks
Quantitative imaging and ECG metrics will compare participants who have a P/LP rare variants linked to an inherited arrhythmia disease gene and will compare to controls. Imaging and ECG metrics will be used to assess adverse structural and electrophysiologic changes to the atria and ventricles from inherited arrhythmia syndromes. Quantitative metrics will be assessed from resting 12- lead ECG, Stress treadmill ECG, and ambulatory ECG monitor. A procainamide challenge will be used on select participants with a non-diagnostic (type II or III) Brugada pattern identified on their previous resting 12-lead ECG or who are P/LP variant carriers in an identified Brugada susceptibility gene. Results will be used to test the hypothesis that cases have increased measures of proarrhythmic structural and electrophysiologic changes compared to controls by imaging and ECG endpoints.
Number of Participants with Changes in Management of Inherited Arrhythmia and CM Syndromes.
Time frame: 6 weeks
The Adjudication Committee will determine the management recommendations for each participant at the time of case review. The primary analysis will focus on changes in each management category (e.g., medical therapy, physical activity restrictions, stroke prophylaxis, implantable cardioverter-defibrillator utilization) that resulted from discovery of a rare variant, and a secondary analysis will compare the management in each category regardless of whether it was pre-existing or newly initiated. The participant will be contacted, the results will be reviewed by the principal investigator or coinvestigators to discuss the results of the testing. Any recommendations regarding clinical care will be communicated to the participants existing physicians and ensure adequate follow-up is arranged or will assist the participant in establishing care with a qualified physician.
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 6 May 2026.
- Results publication: PubMed 32716712Shoemaker MB, Shah RL, Roden DM, Perez MV. How Will Genetics Inform the Clinical Care of Atrial Fibrillation? Circ Res. 2020 Jun 19;127(1):111-127. doi: 10.1161/CIRCRESAHA.120.316365. Epub 2020 Jun 18.
- Results publication: PubMed 34495297Yoneda ZT, Anderson KC, Quintana JA, O'Neill MJ, Sims RA, Glazer AM, Shaffer CM, Crawford DM, Stricker T, Ye F, Wells Q, Stevenson LW, Michaud GF, Darbar D, Lubitz SA, Ellinor PT, Roden DM, Shoemaker MB. Early-Onset Atrial Fibrillation and the Prevalence of Rare Variants in Cardiomyopathy and Arrhythmia Genes. JAMA Cardiol. 2021 Dec 1;6(12):1371-1379. doi: 10.1001/jamacardio.2021.3370.
- How Will Genetics Inform the Clinical Care of Atrial Fibrillation?Link provided by the sponsor.
- Early-Onset Atrial Fibrillation and the Prevalence of Rare Variants in Cardiomyopathy and Arrhythmia GenesLink provided by the sponsor.
- 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.
M. B Shoemaker, MD principal investigator
Vanderbilt University Medical Center
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 Atrial Fibrillation, run by Vanderbilt University Medical Center 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 8 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 6 May 2026. 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 Inherited Cardiomyopathy (CM) Syndromes. (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190679, which also lists 2 linked publications.
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 6 May 2026.