Atrial Fibrillation, Heart Failure
Conditions
Keywords
atrial fibrillation, heart failure, ranolazine, cardioversion, persistent AF, paroxysmal AF
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.
Interventions
DRUGRanolazine
Patients will take ranolazine 1000 mg tablets twice daily
DRUGPlacebo
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Sponsors
Gilead Sciences
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Atrial Fibrillation (AF) Recurrence | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranolazine Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily | 4 |
| Placebo Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study stopped early | 4 | 3 |
Baseline characteristics
| Characteristic | Ranolazine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 89.7 years STANDARD_DEVIATION 9.5 | 84.3 years STANDARD_DEVIATION 9.2 | 78.9 years STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 4 | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranolazine | Time to First Atrial Fibrillation (AF) Recurrence | 0 participants |
| Placebo | Time to First Atrial Fibrillation (AF) Recurrence | 2 participants |