RanolazineNCT00574756
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
A study testing ranolazine in people with Ranolazine and Diastolic Heart Failure, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound
- What is being tested?
- ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate of severe diastolic dysfunction, E/Ea>12
- Preserved systolic function
- NYHA Class I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
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.
- Being tested
- ranolazine
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranolazineDrug
Also called Ranexa
extended release 500 mg twice a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks Receives: Drug: ranolazine |
| 2 | Other | Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks Receives: Drug: ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in E/Ea
Measured: 2 weeks
Secondary outcomes (3)
changes in mitral inflow parameters (E, A, IVRT, DT)
Measured: 2 weeks
Changes in tissue doppler parameters (Ea, Aa)
Measured: 2 weeks
Changes in pulmonary venous inflow (S, D, a reversal)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RanolazineStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony DeMaria, MD, Principal investigator, UCSD Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574756
- Sponsor's protocol ID
- 070480
- Status last verified
- Jul 2019
- First submitted
- 14 Dec 2007
- Last updated
- 2 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT00574756
- Acronym / sponsor ID
- 070480
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no funding
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2007 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ranolazineActive drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks |
| 2 | Other | Drug: ranolazinePlacebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate of severe diastolic dysfunction, E/Ea>12
- Preserved systolic function
- NYHA Class I-II
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranolazineAlso: Ranexaextended release 500 mg twice a day for two weeks | Drug | 1, 2 |
Primary outcome
Change in E/Ea
Time frame: 2 weeks
3 secondary outcomes
changes in mitral inflow parameters (E, A, IVRT, DT)
Time frame: 2 weeks
Changes in tissue doppler parameters (Ea, Aa)
Time frame: 2 weeks
Changes in pulmonary venous inflow (S, D, a reversal)
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: no funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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A Study of Ranolazine in ALS
Amyotrophic Lateral Sclerosis
RecruitingPhase 2/3
Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study
STEMI (ST Elevation MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony DeMaria, MD principal investigator
UCSD Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ranolazine in people with Ranolazine and Diastolic Heart Failure, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in E/Ea (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.