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

June 24, 2013
February 7, 2014
February 2014
January 2015   (final data collection date for primary outcome measure)
Time to first AF recurrence [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01887353 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
April 2015
January 2015   (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.
Both
18 Years and older
No
Contact: T. Jared Bunch, MD 801-507-4701 Jared.Bunch@imail.org
Contact: Patti Spencer 801-507-4778 Patti.Spencer@imail.org
United States
 
NCT01887353
1024475
No
Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
Gilead Sciences
Principal Investigator: T. Jared Bunch, MD Intermountain Medical Center
Intermountain Health Care, Inc.
June 2013

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