Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

This study is currently recruiting participants.

Verified by University of California, San Diego, December 2007

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00574756

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

MedlinePlus related topics: Heart Failure

Drug Information available for: Ranolazine

U.S. FDA Resources

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

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
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

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

Responsible Party:	UCSD Medical Center, Division of Cardiology ( Dr. Anthony DeMaria/Director The Sulpizio Family Cardiovascular Center )
Study ID Numbers:	070480
Study First Received:	December 14, 2007
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00574756
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Ranolazine
Heart Failure, Diastolic
Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009