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

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 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, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure	Ranolazine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on February 27, 2015

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