Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

July 31, 2019 updated by: University of California, San Diego

The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

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
    • California
      • San Diego, California, United States, 92103
        • UCSD Medical Center

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:

  • Moderate of severe diastolic dysfunction, E/Ea>12
  • Preserved systolic function
  • NYHA Class I-II

Exclusion Criteria:

  • QTc >450 msec at enrollment
  • Taking medications that prolong QT interval or are potent inhibitors of CYP3A
  • Significant coronary artery disease
  • Severe valvular disease
  • Hepatic disease
  • Severe kidney disease
  • Women of childbearing age
  • Prior serious ventricular arrhythmia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks
Drug: ranolazine
extended release 500 mg twice a day for two weeks
Other Names:
  • Ranexa
Other: 2
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
Drug: ranolazine
extended release 500 mg twice a day for two weeks
Other Names:
  • Ranexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in E/Ea
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in mitral inflow parameters (E, A, IVRT, DT)
Time Frame: 2 weeks
2 weeks
Changes in tissue doppler parameters (Ea, Aa)
Time Frame: 2 weeks
2 weeks
Changes in pulmonary venous inflow (S, D, a reversal)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Anthony DeMaria, MD, UCSD Medical Center

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 (Actual)

December 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070480

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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