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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00574756
First received: December 14, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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
Ranolazine
Diastolic Heart Failure
Tissue Doppler Ultrasound
Echocardiography
 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:

MedlinePlus related topics: Heart Failure
Drug Information available for: Ranolazine
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in E/Ea [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in mitral inflow parameters (E, A, IVRT, DT) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes in tissue doppler parameters (Ea, Aa) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes in pulmonary venous inflow (S, D, a reversal) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 14, 2007
Last Updated: December 14, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
 Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013