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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00574756
Recruitment Status : Terminated (no funding)
First Posted : December 17, 2007
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Diego

Study Description
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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
Ranolazine Diastolic Heart Failure Tissue Doppler Ultrasound Echocardiography Drug: ranolazine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in E/Ea [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. changes in mitral inflow parameters (E, A, IVRT, DT) [ Time Frame: 2 weeks ]
  2. Changes in tissue doppler parameters (Ea, Aa) [ Time Frame: 2 weeks ]
  3. Changes in pulmonary venous inflow (S, D, a reversal) [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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


Locations
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United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Anthony DeMaria, MD UCSD Medical Center
More Information
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Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00574756    
Other Study ID Numbers: 070480
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases
 Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action