NCT00574756

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

December 14, 2007

Last Update Submit

July 31, 2019

Conditions

RanolazineDiastolic Heart FailureTissue Doppler UltrasoundEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Change in E/Ea

    2 weeks

Secondary Outcomes (3)

  • changes in mitral inflow parameters (E, A, IVRT, DT)

    2 weeks

  • Changes in tissue doppler parameters (Ea, Aa)

    2 weeks

  • Changes in pulmonary venous inflow (S, D, a reversal)

    2 weeks

Study Arms (2)

1

OTHER

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

Drug: ranolazine

2

OTHER

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

Drug: ranolazine

Interventions

ranolazineDRUG

extended release 500 mg twice a day for two weeks

Also known as: Ranexa
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate of severe diastolic dysfunction, E/Ea\>12
  • Preserved systolic function
  • NYHA Class I-II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anthony DeMaria, MD

    UCSD Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 17, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations

US(1)