The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure (RAD HF)
Primary Purpose
Atrial Fibrillation, Heart Failure
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, heart failure, ranolazine, cardioversion, persistent AF, paroxysmal AF
Eligibility 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.
Sites / Locations
- Intermountain Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ranolazine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to First Atrial Fibrillation (AF) Recurrence
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01887353
First Posted
June 24, 2013
Last Updated
July 15, 2015
Sponsor
Intermountain Health Care, Inc.
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01887353
Brief Title
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Acronym
RAD HF
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficultly in enrolling
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure
Keywords
atrial fibrillation, heart failure, ranolazine, cardioversion, persistent AF, paroxysmal AF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Intervention Description
Patients will take ranolazine 1000 mg tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Primary Outcome Measure Information:
Title
Time to First Atrial Fibrillation (AF) Recurrence
Description
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 Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Jared Bunch, MD
Organizational Affiliation
Intermountain Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107-5701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
We'll reach out to this number within 24 hrs