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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Primary Purpose

Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ranolazine
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ranolazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

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

Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks

Outcomes

Primary Outcome Measures

Change in E/Ea

Secondary Outcome Measures

changes in mitral inflow parameters (E, A, IVRT, DT)
Changes in tissue doppler parameters (Ea, Aa)
Changes in pulmonary venous inflow (S, D, a reversal)

Full Information

First Posted
December 14, 2007
Last Updated
July 31, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00574756
Brief Title
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Official Title
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
no funding
Study Start Date
December 2007 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound, Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks
Arm Title
2
Arm Type
Other
Arm Description
Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks
Intervention Type
Drug
Intervention Name(s)
ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
extended release 500 mg twice a day for two weeks
Primary Outcome Measure Information:
Title
Change in E/Ea
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
changes in mitral inflow parameters (E, A, IVRT, DT)
Time Frame
2 weeks
Title
Changes in tissue doppler parameters (Ea, Aa)
Time Frame
2 weeks
Title
Changes in pulmonary venous inflow (S, D, a reversal)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony DeMaria, MD
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

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