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The Genetic Basis for Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491202
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Durham MS, APN, Jesse Brown VA Medical Center

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Genetic Basis for Atrial Fibrillation
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations) [ Time Frame: 1 year ]
  2. heart rate [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491202


Contacts
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Contact: Katherine A Durham, APN 3125696635 Katherine.durham@va.gov

Locations
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United States, Illinois
Jesse Brown VA Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Katherine A Durham, MS, APN    312-569-6635    Katherine.durham@va.gov   
Principal Investigator: Katherine A Durham, MS, APN         
Principal Investigator: Dawood Darbar, MD         
Sponsors and Collaborators
Jesse Brown VA Medical Center
Additional Information:

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Responsible Party: Katherine Durham MS, APN, Cardiology Nurse Practitioner, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier: NCT03491202    
Other Study ID Numbers: 977544
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes