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

November 7, 2013 updated by: University Cardiology

Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active drug
Ranolazine therapy for three months
Drug: Ranolazine (Active drug)
Ranolazine therapy for three months
Other Names:
  • Ranexa
PLACEBO_COMPARATOR: Sugar Pill
sugar pill therapy for three months
Drug: Placebo
Placebo therapy for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effective regurgitant orifice by echocardiography
Time Frame: Day T = 90 days
Day T = 90 days
proximal isovelocity surface area by echocardiography
Time Frame: T = 90 days
T = 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Seattle Angina Questionnaire
Time Frame: T = 0 days, and T = 90 days
T = 0 days, and T = 90 days
Rose Dyspnea Scale
Time Frame: T = 0 days, and T= 90 days
T = 0 days, and T= 90 days

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Reactions
Time Frame: T = 90 day
T = 90 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Cardiology

Investigators

  • Principal Investigator: Raj Baljepally, MD, University Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (ESTIMATE)

November 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-US-259-0173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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