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The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure (RAD HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Intermountain Health Care, Inc.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01887353
First received: June 24, 2013
Last updated: February 7, 2014
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.


Condition Intervention Phase
Atrial Fibrillation
Heart Failure
Drug: Ranolazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Time to first AF recurrence [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine Drug: Ranolazine
Patients will take ranolazine 1000 mg tablets twice daily
Placebo Comparator: Placebo Drug: Placebo
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant female > 18 years of age;
  • Documentation of heart failure and who are in NYHA class II or III;
  • Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
  • Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
  • Demonstration of preserved ejection fraction (EF) by echocardiography;
  • Echocardiographic evidence of impaired diastolic filling.

Exclusion Criteria:

  • Known history of permanent or long-standing AF (> 6 months);
  • Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
  • Known history of cirrhosis;
  • NYHA Class IV;
  • Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
  • Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
  • Clinically significant valvular disease;
  • Clinically significant pulmonary disease;
  • Stroke within 3 months prior to screening;
  • Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;
  • Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
  • Concurrent use of drugs considered strong inhibitors of CYP3A;
  • Concurrent use of drugs considered as CYP3A inducers;
  • Prior treatment with ranolazine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887353

Contacts
Contact: T. Jared Bunch, MD 801-507-4701 Jared.Bunch@imail.org
Contact: Patti Spencer 801-507-4778 Patti.Spencer@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107-5701
Contact: T. Jared Bunch, MD    801-507-4701    Jared.Bunch@imail.org   
Principal Investigator: T. Jared Bunch, MD         
Sub-Investigator: Brian Crandall, MD         
Sub-Investigator: John D Day, MD         
Sub-Investigator: Pete Weiss, MD         
Sub-Investigator: Jeffrey Osborn, MD         
Sub-Investigator: Charles Mallendar, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Gilead Sciences
Investigators
Principal Investigator: T. Jared Bunch, MD Intermountain Medical Center
  More Information

No publications provided

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01887353     History of Changes
Other Study ID Numbers: 1024475
Study First Received: June 24, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
atrial fibrillation
heart failure
ranolazine
cardioversion
persistent AF
paroxysmal AF

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014