The Genetic Basis for Atrial Fibrillation

Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, we look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, we propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation

Detailed Description

Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, the investigators look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, the investigators propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, the investigators will examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.

Patients will be identified through the VA inpatient and outpatient clinic, and will be approached for inclusion in the study. The target enrollment for the research and biorepository is 600 participants. A detailed family history, medical background, study questionnaires and a blood sample will then be obtained by the principal investigator or a research coordinator, following written informed consent under a protocol approved by the Jesse Brown VA Institutional Review Board. Once enough samples are collected, coded DNA samples will be sent out to analyze for linkage to known/candidate loci for AF.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Katherine A Durham, APN; Phone Number: 3125696635; Email: Katherine.durham@va.gov

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Jesse Brown VA Medical Center
      • Contact: Katherine A Durham, MS, APN; Phone Number: 312-569-6635; Email: Katherine.durham@va.gov
      • Principal Investigator: Katherine A Durham, MS, APN
      • Principal Investigator: Dawood Darbar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be identified in the outpatient clinic or in the inpatient setting at the Jesse Brown VA Medical Center and approached for informed consent and HIPAA authorization.

Description

Inclusion Criteria:

• Subjects must be at least 18 years of age, and up to 100.
• Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder.
• Subjects must be willing to give written, informed consent.

Exclusion Criteria:

• Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from the study.
• Subjects who cannot speak English will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
atrial fibrillation; Patients with a diagnosis of atrial fibrillation will be eligible for enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)	1 year
heart rate	1 year

Collaborators and Investigators

• Sponsor: Jesse Brown VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 977544

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No