Ischemic Mitral RegurgitationPhase 4REIN-MRNCT01979965
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
A Phase 4 study testing Ranolazine (Active drug) in people with Ischemic Mitral Regurgitation, run by University Cardiology at 1 site in United States.
Trial summary
The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Mitral Regurgitation
- What is being tested?
- Ranolazine (Active drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2014
- Phase
- Phase 4
- 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
- Ischemic cardiomyopathy AND
- Moderate or severe mitral regurgitation AND
- Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
- Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)
Who cannot join
- nonischemic cardiomyopathy
- active heart failure
- current ranolazine therapy
- congenital heart disease
- mechanical valve prostheses
- vegetation/endocarditis
Show all 15Show fewer
- significant pulmonary disease
- peripheral vascular disease
- trivial or mild mitral regurgitation
- creatinine clearance < 30 mL/min
- liver cirrhosis
- strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
- strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
- Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
- Initial QTc interval ≥ 440msec
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.
- Conditions
- Ischemic Mitral Regurgitation
- Being tested
- Ranolazine (Active drug), Placebo
- Keywords
- Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranolazine (Active drug)Drug
Also called Ranexa
Ranolazine therapy for three months
PlaceboDrug
Placebo therapy for three months
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | Ranolazine therapy for three months Receives: Drug: Ranolazine (Active drug) |
| Sugar Pill | Placebo comparator | sugar pill therapy for three months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective regurgitant orifice by echocardiography
Measured: Day T = 90 days
proximal isovelocity surface area by echocardiography
Measured: T = 90 days
Secondary outcomes (2)
Seattle Angina Questionnaire
Measured: T = 0 days, and T = 90 days
Rose Dyspnea Scale
Measured: T = 0 days, and T= 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Mitral RegurgitationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raj Baljepally, MD, Principal investigator, University Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979965
- Sponsor's protocol ID
- IN-US-259-0173
- Acronym
- REIN-MR
- Status last verified
- Nov 2013
- First submitted
- 23 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01979965
- Acronym / sponsor ID
- REIN-MR / IN-US-259-0173
- Conditions
- Ischemic Mitral Regurgitation
- Keywords
- Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University CardiologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 8 Nov 2013 (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 find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Drug: Ranolazine (Active drug)Ranolazine therapy for three months |
| Sugar Pill | Placebo comparator | Drug: Placebosugar pill therapy for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic cardiomyopathy AND
- Moderate or severe mitral regurgitation AND
- Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
- Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)
Key exclusion criteria (15 listed)
- nonischemic cardiomyopathy
- active heart failure
- current ranolazine therapy
- congenital heart disease
- mechanical valve prostheses
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 |
|---|---|---|
| Ranolazine (Active drug)Also: RanexaRanolazine therapy for three months | Drug | Active drug |
| PlaceboPlacebo therapy for three months | Drug | Sugar Pill |
Primary outcome
effective regurgitant orifice by echocardiography
Time frame: Day T = 90 days
proximal isovelocity surface area by echocardiography
Time frame: T = 90 days
2 secondary outcomes
Seattle Angina Questionnaire
Time frame: T = 0 days, and T = 90 days
Rose Dyspnea Scale
Time frame: T = 0 days, and T= 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- University CardiologyLink provided by the sponsor.
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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.
Raj Baljepally, MD principal investigator
University Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine (Active drug) in people with Ischemic Mitral Regurgitation, run by University Cardiology 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Nov 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
effective regurgitant orifice by echocardiography (time frame: Day T = 90 days). The study lists 2 primary outcomes in all. 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 8 Nov 2013.