We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Difficultly in enrolling)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887353
First Posted: June 26, 2013
Last Update Posted: July 20, 2015
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.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
  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
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887353


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

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01887353     History of Changes
Other Study ID Numbers: 1024475
First Submitted: June 24, 2013
First Posted: June 26, 2013
Results First Submitted: April 9, 2015
Results First Posted: July 20, 2015
Last Update Posted: July 20, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action