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Effect of Ranolazine on Valvular Disease in Patients With Pacemakers (REIN-MR)

U

University Cardiology

Status and phase

Unknown
Phase 4

Conditions

Ischemic Mitral Regurgitation

Treatments

Drug: Ranolazine (Active drug)
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01979965
IN-US-259-0173

Details and patient eligibility

About

The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ischemic cardiomyopathy AND
  • Moderate or severe mitral regurgitation AND
  • Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
  • Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)

Exclusion criteria

  • nonischemic cardiomyopathy
  • active heart failure
  • current ranolazine therapy
  • congenital heart disease
  • mechanical valve prostheses
  • vegetation/endocarditis
  • significant pulmonary disease
  • peripheral vascular disease
  • trivial or mild mitral regurgitation
  • creatinine clearance < 30 mL/min
  • liver cirrhosis
  • strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
  • strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
  • Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
  • Initial QTc interval ≥ 440msec

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Active drug
Active Comparator group
Description:
Ranolazine therapy for three months
Treatment:
Drug: Ranolazine (Active drug)
Sugar Pill
Placebo Comparator group
Description:
sugar pill therapy for three months
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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