Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Primary Purpose
Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ranolazine
Sponsored by
About this trial
This is an interventional treatment trial for Ranolazine
Eligibility Criteria
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
Sites / Locations
- UCSD Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
Outcomes
Primary Outcome Measures
Change in E/Ea
Secondary Outcome Measures
changes in mitral inflow parameters (E, A, IVRT, DT)
Changes in tissue doppler parameters (Ea, Aa)
Changes in pulmonary venous inflow (S, D, a reversal)
Full Information
NCT ID
NCT00574756
First Posted
December 14, 2007
Last Updated
July 31, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00574756
Brief Title
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Official Title
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
no funding
Study Start Date
December 2007 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound, Echocardiography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks
Arm Title
2
Arm Type
Other
Arm Description
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
Intervention Type
Drug
Intervention Name(s)
ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
extended release 500 mg twice a day for two weeks
Primary Outcome Measure Information:
Title
Change in E/Ea
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
changes in mitral inflow parameters (E, A, IVRT, DT)
Time Frame
2 weeks
Title
Changes in tissue doppler parameters (Ea, Aa)
Time Frame
2 weeks
Title
Changes in pulmonary venous inflow (S, D, a reversal)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony DeMaria, MD
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
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