DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017