RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain

Withdrawn before enrolling

Conditions studied: Severe Coronary Artery Disease, Ischaemic Myocardial Dysfunction

In brief

The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.

Key facts

Study ID

NCT03257683

Run by

Saint Thomas Health

People needed

0

Starts

2017-04-14

Expected to finish

2018-02-16

Last updated by the study team

2018-04-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age > 18 Stable GDMT for 60 days prior to enrollment Normal sinus rhythm Coronary artery revascularization > 60 days prior to enrollment Non-revascularizable area of myocardial ischemia as determined by stress MRI Able to perform the bicycle stress echocardiograms Able to provide written, informed consent Women of childbearing potential with negative pregnancy test at the index visit, and consent to use effective contraception throughout the study period and up to at least 14 days following the last dose of study drug

You may not qualify if…

• More than 1+MR, aortic stenosis, aortic insufficiency, mitral stenosis Serious co-morbidities with predicted life expectancy <1 year Patients not in normal sinus rhythm (NSR) Patients who have undergone coronary artery revascularization (PCI, CABG) within 60 days Pregnant or unknown pregnancy status Liver cirrhosis Patients unwilling/unable to provide written, informed consent Concomitant use of QTc prolonging drugs, potassium channel variants resulting in a long QT interval, patients with a family history of (or congenital) long QT syndrome, and patients with known acquired QT interval prolongation Concomitant use of strong CYP3A inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir Concomitant use of CYP3A4 inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort Breast feeding Atrial fibrillation or frequent atrial or ventricular ectopy Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin) P-gp inhibitors (e.g., cyclosporine) which increase ranolazine exposure Renal failure. Patients with Creatinine clearance less than 30ml/min . Safety Considerations for patients with the following drugs/conditions CYP3A substrates: Limit simvastatin to 20 mg when used with ranolazine. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ranolazine OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ranolazine 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ranolazine Renal failure: Patients with creatinine clearance less than 30ml/min are excluded from participation in this study. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL < 60 mL/min). If acute renal failure develops, discontinue ranolazine.

Where it is running

• Saint Thomas Heart at Saint Thomas West — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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