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

This study has been terminated.
(Difficultly in enrolling)
Gilead Sciences
Information provided by (Responsible Party):
Intermountain Health Care, Inc. Identifier:
First received: June 24, 2013
Last updated: July 15, 2015
Last verified: April 2015
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Atrial Fibrillation (AF) Recurrence [ Time Frame: up to 6 months ]
    There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead

Enrollment: 8
Study Start Date: June 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01887353

United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107-5701
Sponsors and Collaborators
Intermountain Health Care, Inc.
Gilead Sciences
Principal Investigator: T. Jared Bunch, MD Intermountain Medical Center
  More Information

Responsible Party: Intermountain Health Care, Inc. Identifier: NCT01887353     History of Changes
Other Study ID Numbers: 1024475
Study First Received: June 24, 2013
Results First Received: April 9, 2015
Last Updated: July 15, 2015

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

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017