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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Sponsor
University of California, San Diego (Other)
Overall Status
Terminated
CT.gov ID
NCT00574756
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
27
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Actual Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in E/Ea [2 weeks]

    Secondary Outcome Measures

    1. changes in mitral inflow parameters (E, A, IVRT, DT) [2 weeks]

    2. Changes in tissue doppler parameters (Ea, Aa) [2 weeks]

    3. Changes in pulmonary venous inflow (S, D, a reversal) [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD Medical Center San Diego California United States 92103

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT00574756
    Other Study ID Numbers:
    • 070480
    First Posted:
    Dec 17, 2007
    Last Update Posted:
    Aug 2, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Heart Failure, Diastolic
    Ranolazine

    Study Results

    No Results Posted as of Aug 2, 2019