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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Cardiology
ClinicalTrials.gov Identifier:
NCT01979965
First received: October 23, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Mitral Regurgitation
Drug: Ranolazine (Active drug)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by University Cardiology:

Primary Outcome Measures:
  • effective regurgitant orifice by echocardiography [ Time Frame: Day T = 90 days ] [ Designated as safety issue: No ]
  • proximal isovelocity surface area by echocardiography [ Time Frame: T = 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seattle Angina Questionnaire [ Time Frame: T = 0 days, and T = 90 days ] [ Designated as safety issue: No ]
  • Rose Dyspnea Scale [ Time Frame: T = 0 days, and T= 90 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse Reactions [ Time Frame: T = 90 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active drug
Ranolazine therapy for three months
Drug: Ranolazine (Active drug)
Ranolazine therapy for three months
Other Name: Ranexa
Placebo Comparator: Sugar Pill
sugar pill therapy for three months
Drug: Placebo
Placebo therapy for three months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979965

Locations
United States, Tennessee
University Cardiology
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University Cardiology
Investigators
Principal Investigator: Raj Baljepally, MD University Cardiology
  More Information

Additional Information:
No publications provided

Responsible Party: University Cardiology
ClinicalTrials.gov Identifier: NCT01979965     History of Changes
Other Study ID Numbers: IN-US-259-0173
Study First Received: October 23, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Cardiology:
Mitral Regurgitation
cardiac resynchronization therapy
ranolazine
maximal medical therapy
ischemic cardiomyopathy

Additional relevant MeSH terms:
Ischemia
Mitral Valve Insufficiency
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014