[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559925":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":101,"collaborators":103,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":23,"enrollmentInfo":123,"targetDuration":23,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin","EXPERIMENTAL","Participants in the empagliflozin arm will receive 10 mg by mouth once daily and standard of care.",[13],"Drug: Empagliflozin",{"label":15,"type":10,"description":16,"interventionNames":17},"Ranolazine","Participants in the ranolazine arm will receive ranolazine 500 mg by mouth twice daily, which will be increased to 1000 mg twice daily after 2 weeks (unless concurrently using moderate CYP 3A4 inhibitors, then dose is limited to 500 mg twice daily) and will receive standard of care.",[18],"Drug: Ranolazine",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard of Care","NO_INTERVENTION","Participants in this group will receive standard of care.",null,[25,31],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Tablet",[9],[30],"Jardiance",{"type":26,"name":15,"description":27,"armGroupLabels":32,"otherNames":33},[15],[34],"Corzyna",[36],{"name":37,"affiliation":5,"role":38},"Jason Weatherald, MD,MSc,FRCPC","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":23,"email":43},"CONTACT","780-492-9937","weathera@ualberta.ca",{"name":45,"role":41,"phone":46,"phoneExt":23,"email":47},"Courtney Gubbels, BA","780-492-1113","courtney.gubbels@ualberta.ca",[49,63,72,82,92],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":23},"University of Calgary","NOT_YET_RECRUITING","Calgary","Alberta","T1Y 6J4","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-114.08529,51.05011,{"lat":61,"lon":60},{"facility":5,"status":64,"city":65,"state":53,"zip":66,"country":55,"countryCode":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":23},"RECRUITING","Edmonton","T6G 2G3",{"type":58,"coordinates":68},[69,70],-113.46871,53.55014,{"lat":70,"lon":69},{"facility":73,"status":51,"city":74,"state":75,"zip":76,"country":55,"countryCode":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":23},"The University of British Columbia","Vancouver","British Columbia","V5Z 1M9",{"type":58,"coordinates":78},[79,80],-123.11934,49.24966,{"lat":80,"lon":79},{"facility":83,"status":51,"city":84,"state":85,"zip":86,"country":55,"countryCode":56,"cosmosGeoPoint":87,"geoPoint":91,"contacts":23},"London Health Sciences Centre - University Hospital","London","Ontario","N6A 5A5",{"type":58,"coordinates":88},[89,90],-81.23304,42.98339,{"lat":90,"lon":89},{"facility":93,"status":51,"city":94,"state":85,"zip":95,"country":55,"countryCode":56,"cosmosGeoPoint":96,"geoPoint":100,"contacts":23},"The Ottawa Hospital","Ottawa","K1Y 4E9",{"type":58,"coordinates":97},[98,99],-75.69812,45.41117,{"lat":99,"lon":98},{"type":102,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[104,107,109,111],{"name":105,"class":106},"Canadian Heart Function Alliance","UNKNOWN",{"name":108,"class":6},"Accelerating Clinical Trials Consortium",{"name":110,"class":6},"Ottawa Heart Institute Research Corporation",{"name":112,"class":106},"Team PHenomenal Hope","100559925","phase-2-feasibility-trial-for-a-right-ventricular-failure-platform-trial-100559925",false,"NCT06570473","Feasibility Trial for a Right Ventricular Failure Platform Trial","Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure","CRAVE","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Able to provide informed consent.\n3. Able to comply with all study procedures.\n4. History of RV dysfunction or RHF secondary to any of:\n\n   a. Group 1 PH, pulmonary arterial hypertension b. Group 2 PH, left heart disease with normal left ventricular ejection fraction (LVEF) \\> 50% and a previous RHC demonstrating combined pre and post-capillary PH, defined as: i. mPAP \\>20 mmHg ii. PAWP \\> 15 mmHg iii. PVR\\> 2 WU c. Group 3 PH d. Group 4 PH, chronic thromboembolic PH that is either persistent after pulmonary endarterectomy or inoperable due to distal disease.\n5. Symptomatic with current NYHA Functional Class II-IV\n6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:\n\n   1. NT-proBNP \\>300 ng\u002FL and qualitative evidence of at least 'mild' RV dysfunction on echocardiography OR NT-proBNP\\\u003C300 ng\u002FL and qualitative evidence of at least moderate RV dysfunction and\u002For dilatation on 2D echocardiogram AND\n   2. A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following:\n\n   i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \\> 42 mm at the base).\n7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.\n8. Access to an iOS or android smart phone or tablet.\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin.\n2. LVEF \\\u003C 50%\n3. Normal RV size and function\n4. Severe aortic or mitral valvular disease\n5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)\n6. Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability\n7. Pregnancy or lactation\n8. Unable to provide consent and comply with follow-up visits\n9. Listed for lung, heart or heart\u002Flung transplantation\n10. Myocardial infarction or acute coronary syndrome within 90 days of screening\n11. Enrolled in another interventional trial\n12. Planned cardiac or thoracic surgical intervention in the next 6 months.\n13. Known hypersensitivity to empagliflozin or ranolazine.\n14. Concurrent treatment with:\n\n    * strong inhibitors of Cytochrome P450 3A4 (CYP 3A4), (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, nelfinavir, ritonavir, indinavir, saquinavir and grapefruit juice)\n    * class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmics (e.g., sotalol, ibutilide, amiodarone, dronedarone)\n    * inducers of CYP 3A4 (e.g., rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)\n15. Congenital long QT syndrome or a QTc interval \\>500 ms","ALL","18 Years",{"count":124,"type":125},30,"ESTIMATED","INTERVENTIONAL",[128],"PHASE2","The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.",[131,132,133],"Pulmonary Hypertension","Right Ventricular Dysfunction","Right Heart Failure",[131,132,133,9,15],"2025-09-16",{"date":137,"type":138},"2025-09-18","ACTUAL",{"date":140,"type":138},"2025-07-15",{"date":142,"type":125},"2026-12",{"name":5,"class":6},5]