Certain People With Atrial Fibrillation May Have Changes on Ecg When Given Procainamide That May be Related to a Genetic Difference
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Procainamide (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Dawood Darbar, MD, PhD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact: Gayle Kucera, RN, Phone: 615-936-6069, Email: gayle.a.kucera@vanderbilt.edu
Summary
The purpose of this study is to look for a similarity in people's genes that may help
understand which people could benefit from certain drugs for the treatment of atrial
fibrillation.
Clinical Details
Official title: Prospective Evaluation of a Potential Sodium Channel-Related Endophenotype
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: ST segment elevation ≥ 1 mm in the right precordial leads (V1-V3), either at baseline or manifested after Na+ channel block with intravenous procainamide
Detailed description:
Current drug therapies to suppress AF are incompletely and unpredictably effective and carry
significant (albeit generally small) risks of serious adverse effects, including
drug-induced long QT syndrome (diLQTS), other forms of proarrhythmia, increased mortality
through uncertain mechanisms, and extracardiac toxicity. Identification of clinical and
genetic subtypes of AF will permit stratification of therapeutic approaches and thereby
facilitate the practice of personalized medicine. Furthermore, limited success of drug
therapy and increase in drug toxicity in AF is probably because the arrhythmia represents a
final common pathway of multiple initiating mechanisms, including those some that are
genetically-defined.
Identifying specific intermediate phenotypes ("endophenotypes") associated with defined
clinical courses in AF represents a potential method to systematically subtype patients by
underlying mechanism and represents a much-needed clinical advance. Clinical endophenotypes
that have been studied include atrial fibrillatory rate, prolonged signal-averaged P-wave
duration, and biomarker profiles. The endophenotype we will study here is right precordial
ST segment elevation, seen not only in Brugada syndrome (BrS) (where it is unmasked by
sodium channel blocking drugs) but also commonly in lone AF and in patients with
AF-associated rare variants in genes encoding the cardiac sodium channel α- or β-subunits.
Taken together these data suggest the hypothesis to be tested in this study, that variants
in multiple genes can culminate in a similar AF-prone substrate by reducing sodium current
that can be identified by screening for baseline or manifest right precordial ST segment
elevation endophenotype after sodium channel block with intravenous procainamide.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years of age or older
- Undergoing AF ablation at Vanderbilt or MGH
Exclusion Criteria:
- Patients taking membrane active anti-arrhythmic drugs with sodium channel blocking
properties (amiodarone, dronedarone, flecainide, propafenone) at the time of the
ablation
- Patients with a history of Brugada syndrome or type 1 Brugada ECG pattern on the
baseline ECG
- Patients with a history of drug-induced torsades de pointes
- Patients with a known history of hypersensitivity to procainamide, procaine or
related drugs
- Patients with a history of systemic lupus erythematosus and myasthenia gravis
- Patients with a history of second degree AV block (Mobitz type II) or third degree AV
block
- Women of child-bearing potential unless post-menopausal, surgically sterile, or have
a negative pregnancy test day on the day of procedure
- Patients with dual chamber pacemakers or implantable defibrillators requiring
ventricular pacing (uninterpretable ECG)
- Patients unable to give informed consent
Locations and Contacts
Gayle Kucera, RN, Phone: 615-936-6069, Email: gayle.a.kucera@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting Gayle Kucera, RN, Phone: 615-936-6069, Email: gayle.a.kucera@vanderbilt.edu Kris Norris, RN, Phone: 615-936-1131, Email: kris.norris@vanderbilt.edu
Additional Information
Starting date: November 2010
Last updated: December 9, 2014
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