The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

NCT01887353 | Terminated Phase 2 Results

• 1 other identifier: 1024475
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

atrial fibrillation; heart failure; ranolazine; cardioversion; persistent AF; paroxysmal AF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ranolazine DRUG

Patients will take ranolazine 1000 mg tablets twice daily

Ranolazine

Placebo DRUG

Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107-5701, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: T. Jared Bunch
• Organization: Intermountain Healthcare

jared.bunch@imail.org

8015074701

Study Officials

• T. Jared Bunch, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 20, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-04

Locations

US (1)