The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Phase 2

Terminated

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Drug: Placebo; Drug: Ranolazine

• Registration Number: NCT01887353
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-04
• Results First Submitted: 2015-04-09
• Results First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Results First Posted: 2015-07-20
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ranolazine	Ranolazine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States