Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
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ClinicalTrials.gov Identifier: NCT00574756 |
Recruitment Status
: Unknown
Verified December 2007 by University of California, San Diego.
Recruitment status was: Recruiting
First Posted
: December 17, 2007
Last Update Posted
: December 17, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ranolazine Diastolic Heart Failure Tissue Doppler Ultrasound Echocardiography | Drug: ranolazine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 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 |
Study Start Date : | December 2007 |
Estimated Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
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 Name: Ranexa
|
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 Name: Ranexa
|
- Change in E/Ea [ Time Frame: 2 weeks ]
- changes in mitral inflow parameters (E, A, IVRT, DT) [ Time Frame: 2 weeks ]
- Changes in tissue doppler parameters (Ea, Aa) [ Time Frame: 2 weeks ]
- Changes in pulmonary venous inflow (S, D, a reversal) [ Time Frame: 2 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574756
Contact: Wendy Austin, MD | 619-543-8213 | waustin@ucsd.edu |
United States, California | |
UCSD Medical Center | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Wendy Austin, MD 619-543-8213 waustin@ucsd.edu | |
Sub-Investigator: Wendy Austin, MD | |
Sub-Investigator: Ori Ben-Yehuda, MD | |
Sub-Investigator: Dan Blanchard, MD | |
Principal Investigator: Anthony DeMaria, MD |
Principal Investigator: | Anthony DeMaria, MD | UCSD Medical Center |
Responsible Party: | Dr. Anthony DeMaria/Director The Sulpizio Family Cardiovascular Center, UCSD Medical Center, Division of Cardiology |
ClinicalTrials.gov Identifier: | NCT00574756 History of Changes |
Other Study ID Numbers: |
070480 |
First Posted: | December 17, 2007 Key Record Dates |
Last Update Posted: | December 17, 2007 |
Last Verified: | December 2007 |
Additional relevant MeSH terms:
Heart Failure Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |
Ranolazine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |