- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574756
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
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
-
-
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
|
extended release 500 mg twice a day for two weeks
Other Names:
|
Other: 2
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
|
extended release 500 mg twice a day for two weeks
Other Names:
|
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.
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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