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Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure

Information source: ARCA Biopharma, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Current or Recent History of Atrial Fibrillation

Intervention: bucindolol hydrochloride (Drug); metoprolol succinate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: ARCA Biopharma, Inc.

Official(s) and/or principal investigator(s):
Jonathan Piccini, MD, Principal Investigator, Affiliation: Duke University
Chris Dufton, PhD, Study Director, Affiliation: ARCA Biopharma, Inc.

Overall contact:
Jennifer Meriwether, Phone: 720-940-2132, Email: jennifer.meriwether@arcabiopharma.com

Summary

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

Clinical Details

Official title: GENETIC-AF - A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to first event of symptomatic atrial fibrillation/atrial flutter (AF/AFL) or all cause mortality (ACM) during the 24-week Follow-up Period after establishment of stable sinus rhythm (SR) on study drug

Secondary outcome:

Time to first event of AF/AFL (i.e., symptomatic or asymptomatic) or ACM during the 24-week Follow-up Period

Proportion of patients with ventricular tachycardia (VT), ventricular fibrillation (VF), or symptomatic supraventricular tachycardia (SVT) during the 24-week Follow-up Period

Total number of hospitalization days per patient (all-cause) during the Total Study Period

Time to first event of AF/AFL (i.e., symptomatic or asymptomatic), heart failure (HF) hospitalization (as assessed by the Investigator), or ACM during the Total Study Period

Proportion of patients who have AF/AFL on ECG at the end of study who demonstrate ventricular response rate (VRR) control

Detailed description: The goal of the GENETIC-AF trial is to demonstrate the superiority of pharmacogenetically targeted bucindolol compared to metoprolol for the prevention of symptomatic atrial fibrillation or atrial flutter in a genotype-defined population with heart failure and/or reduced left ventricular ejection fraction at high risk of atrial fibrillation/atrial flutter recurrence.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Must weigh ≥ 40 kg

- Possess the β1389 Arg/Arg genotype

- Left Ventricular Ejection Fraction (LVEF) < 0. 50 assessed ≤ 12 months prior to

Screening

- At least one episode of symptomatic paroxysmal or persistent AF within ≤ 120 days of

Screening

- Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present 3

weeks after study drug initiation

- Clinical euvolemia at the time of Randomization

- Receiving appropriate anticoagulation therapy prior to Randomization

Key Exclusion Criteria:

- NYHA Class IV symptoms at the time of Randomization

- Permanent AF at Screening

- More than two previous ECV ≤ 12 months of Screening or if the most recent ECV failed

to produce SR

- History of a successful atrioventricular (AV) node ablation

- History of an AF ablation within 30 days of Randomization

- Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD)

device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90 days of Randomization

Locations and Contacts

Jennifer Meriwether, Phone: 720-940-2132, Email: jennifer.meriwether@arcabiopharma.com

ARCA Clinical Research Site #615, Quebec G1V 4G5, Canada; Recruiting

ARCA Clinical Research Site #157, Anchorage, Alaska 99508, United States; Recruiting

ARCA Clinical Research Site #612, Calgary, Alberta T2N 4Z6, Canada; Recruiting

ARCA Clinical Research Site #624, Vancouver, British Columbia V6E 1M7, Canada; Recruiting

ARCA Clinical Research Site #605, Victoria, British Columbia V8R 4R2, Canada; Recruiting

ARCA Clinical Research Site #320, Pasadena, California 91105, United States; Recruiting

ARCA Clinical Research Site # 132, Sacramento, California 95816, United States; Recruiting

ARCA Clinical Research Site #153, Aurora, Colorado 80045, United States; Recruiting

ARCA Clinical Research Site #380, Denver, Colorado 80120, United States; Recruiting

ARCA Clinical Research Site #195, Miami, Florida 33136, United States; Recruiting

ARCA Clinical Research Site #184, Tampa, Florida 33606, United States; Recruiting

ARCA Clinical Research Site #351, Athens, Georgia 30606, United States; Recruiting

ARCA Clinical Research Site #194, Gurnee, Illinois 60031, United States; Recruiting

ARCA Clinical Research Site #342, Oakbrook Terrace, Illinois 60181, United States; Recruiting

ARCA Clinical Research Site #303, Hammond, Indiana 46320, United States; Recruiting

ARCA Clinical Research Site #355, Indianapolis, Indiana 46260, United States; Recruiting

ARCA Clinical Research Site #105, Royal Oak, Michigan 48703, United States; Recruiting

ARCA Clinical Research Site #127, Ypsilanti, Michigan 48197, United States; Recruiting

ARCA Clinical Research Site #156, Minneapolis, Minnesota 55417, United States; Recruiting

ARCA Clinical Research Site #174, St Paul, Minnesota 55102, United States; Recruiting

ARCA Clinical Research Site #108, St. Louis, Missouri 63110, United States; Recruiting

ARCA Clinical Research Site #152, Lincoln, Nebraska 68506, United States; Recruiting

ARCA Clinical Research Site #176, Omaha, Nebraska 68198, United States; Recruiting

ARCA Clinical Research Site #161, Elmer, New Jersey 08318, United States; Recruiting

ARCA Clinical Research Site # 179, Albany, New York 12205, United States; Recruiting

ARCA Clinical Research Site #181, Durham, North Carolina 27705, United States; Recruiting

ARCA Clinical Research Site #349, Greensboro, North Carolina 27401, United States; Recruiting

ARCA Clinical Research Site #173, Akron, Ohio 44304, United States; Recruiting

ARCA Clinical Research Site #322, Cleveland, Ohio 44106, United States; Recruiting

ARCA Clinical Research Site #151, Columbus, Ohio 43210, United States; Recruiting

ARCA Clinical Research Site #123, Oklahoma City, Oklahoma 73120, United States; Recruiting

ARCA Clinical Research Site #611, Cambridge, Ontario N1R 6V6, Canada; Recruiting

ARCA Clinical Research Site #621, Cambridge, Ontario N1R 7R1, Canada; Recruiting

ARCA Clinical Research Site #601, Hamilton, Ontario L8L 2X2, Canada; Recruiting

ARCA Clinical Research Site #609, London, Ontario N6A 5A5, Canada; Recruiting

ARCA Clinical Research Site #623, Newmarket, Ontario L3Y 2P6, Canada; Recruiting

ARCA Clinical Research Site #618, Oshawa, Ontario L1H 1B9, Canada; Recruiting

ARCA Clinical Research Site #622, Oshawa, Ontario L1J 2J9, Canada; Recruiting

ARCA Clinical Research Site #613, Ottawa, Ontario K1Y 4W7, Canada; Recruiting

ARCA Clinical Research Site #616, Waterloo, Ontario N2J 1C4, Canada; Recruiting

ARCA Clinical Research Site #115, Portland, Oregon 97201, United States; Recruiting

ARCA Clinical Research Site # 189, Hershey, Pennsylvania 17033, United States; Recruiting

ARCA Clinical Research Site #109, Lancaster, Pennsylvania 17603, United States; Recruiting

ARCA Clinical Research Site #142, Pittsburgh, Pennsylvania 15212, United States; Recruiting

ARCA Clinical Research Site #614, Montreal, Quebec H1T 1C8, Canada; Recruiting

ARCA Clinical Research Site #602, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting

ARCA Clinical Research Site #198, Jackson, Tennessee 38305, United States; Recruiting

ARCA Clinical Research Site #170, Nashville, Tennessee 37232, United States; Recruiting

ARCA Clinical Research Site #316, Austin, Texas 78705, United States; Recruiting

ARCA Clinical Research Site #160, Beaumont, Texas 77702, United States; Recruiting

ARCA Research Site #131, Norfolk, Virginia 23507, United States; Recruiting

ARCA Clinical Research Site #196, Puyallup, Washington 98372, United States; Recruiting

Additional Information

Related publications:

Liggett SB, Mialet-Perez J, Thaneemit-Chen S, Weber SA, Greene SM, Hodne D, Nelson B, Morrison J, Domanski MJ, Wagoner LE, Abraham WT, Anderson JL, Carlquist JF, Krause-Steinrauf HJ, Lazzeroni LC, Port JD, Lavori PW, Bristow MR. A polymorphism within a conserved beta(1)-adrenergic receptor motif alters cardiac function and beta-blocker response in human heart failure. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11288-93. Epub 2006 Jul 14.

O'Connor CM, Fiuzat M, Carson PE, Anand IS, Plehn JF, Gottlieb SS, Silver MA, Lindenfeld J, Miller AB, White M, Walsh R, Nelson P, Medway A, Davis G, Robertson AD, Port JD, Carr J, Murphy GA, Lazzeroni LC, Abraham WT, Liggett SB, Bristow MR. Combinatorial pharmacogenetic interactions of bucindolol and β1, α2C adrenergic receptor polymorphisms. PLoS One. 2012;7(10):e44324. doi: 10.1371/journal.pone.0044324. Epub 2012 Oct 10.

Aleong RG, Sauer WH, Sauer WH, Murphy GA, Port JD, Anand IS, Fiuzat M, O'Connor CM, Abraham WT, Liggett SB, Bristow MR. Prevention of atrial fibrillation by bucindolol is dependent on the beta₁389 Arg/Gly adrenergic receptor polymorphism. JACC Heart Fail. 2013 Aug;1(4):338-44.

Kao DP, Davis G, Aleong R, O'Connor CM, Fiuzat M, Carson PE, Anand IS, Plehn JF, Gottlieb SS, Silver MA, Lindenfeld J, Miller AB, White M, Murphy GA, Sauer W, Bristow MR. Effect of bucindolol on heart failure outcomes and heart rate response in patients with reduced ejection fraction heart failure and atrial fibrillation. Eur J Heart Fail. 2013 Mar;15(3):324-33. doi: 10.1093/eurjhf/hfs181. Epub 2012 Dec 7.

Starting date: April 2014
Last updated: August 3, 2015

Page last updated: August 23, 2015

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