Understanding genetic factors in early-onset atrial fibrillation
Prospective Phenotyping for Genetic Subtypes of Early-onset Atrial Fibrillation
This study is trying to find out how genetics affect early-onset atrial fibrillation in people by looking at their heart health and comparing those with certain gene changes to others without them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05190679 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the genetic underpinnings of early-onset atrial fibrillation (AF) by enrolling 225 participants who have undergone genetic sequencing for arrhythmia and cardiomyopathy genes. Participants will undergo comprehensive cardiac phenotyping, including cardiac MRI and ECG monitoring, to identify any underlying genetic diseases. The study will compare individuals with pathogenic variants to matched controls to assess the impact of these genetic factors on cardiac health and treatment options. If a genetic syndrome is identified, tailored medical care will be recommended based on established guidelines.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with atrial fibrillation before the age of 65 who have undergone genetic testing and have pathogenic or likely pathogenic variants.
Not a fit: Patients who are pregnant or do not have a diagnosis of atrial fibrillation prior to age 65 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with early-onset atrial fibrillation based on their genetic profiles.
How similar studies have performed: Other studies have shown promise in understanding genetic factors in arrhythmias, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: -Pregnant women
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: M. B Shoemaker, MD — Vanderbilt University Medical Center
- Study coordinator: Hollie Williams, MSN
- Email: Hollie.Williams@vumc.org
- Phone: 615-875-0405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.