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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01887353
Recruitment Status : Terminated (Difficultly in enrolling)
First Posted : June 26, 2013
Results First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Gilead Sciences
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

June 24, 2013
June 26, 2013
April 9, 2015
July 20, 2015
July 20, 2015
June 2013
February 2014   (Final data collection date for primary outcome measure)
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
Time to first AF recurrence [ Time Frame: up to 6 months ]
Complete list of historical versions of study NCT01887353 on Archive Site
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The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
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
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Heart Failure
  • Drug: Ranolazine
    Patients will take ranolazine 1000 mg tablets twice daily
  • Drug: Placebo
    Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
  • Active Comparator: Ranolazine
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
Gilead Sciences
Principal Investigator: T. Jared Bunch, MD Intermountain Medical Center
Intermountain Health Care, Inc.
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP