The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01887353
• Other study ID #: 1024475
• Status: Terminated
• Phase: Phase 2
• First received: June 24, 2013
• Last updated: July 15, 2015
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Drug:
• Ranolazine
Patients will take ranolazine 1000 mg tablets twice daily
• Placebo
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	up to 6 months	No