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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
Sponsor:
Information provided by:
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)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

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, Senior)
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


Contacts
Contact: Wendy Austin, MD 619-543-8213 waustin@ucsd.edu

Locations
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         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Anthony DeMaria, MD UCSD Medical Center
More Information
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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