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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by University of California, San Diego.
Recruitment status was:  Recruiting
Information provided by:
University of California, San Diego Identifier:
First received: December 14, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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 Intervention
Diastolic Heart Failure
Tissue Doppler Ultrasound
Drug: ranolazine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
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
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00574756

United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Anthony DeMaria, MD UCSD Medical Center
  More Information

Responsible Party: Dr. Anthony DeMaria/Director The Sulpizio Family Cardiovascular Center, UCSD Medical Center, Division of Cardiology Identifier: NCT00574756     History of Changes
Other Study ID Numbers: 070480 
Study First Received: December 14, 2007
Last Updated: December 14, 2007

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on February 20, 2017