Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

NCT ID: NCT00574756

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ranolazine Diastolic Heart Failure Tissue Doppler Ultrasound Echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks

Group Type OTHER

ranolazine

Intervention Type DRUG

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

Group Type OTHER

ranolazine

Intervention Type DRUG

extended release 500 mg twice a day for two weeks

Interventions

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ranolazine

extended release 500 mg twice a day for two weeks

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony DeMaria, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Medical Center

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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070480

Identifier Type: -

Identifier Source: org_study_id

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