Feasibility Trial for a Right Ventricular Failure Platform Trial

Phase 2

Not yet recruiting

• Conditions: Right Ventricular Dysfunction; Pulmonary Hypertension; Right Heart Failure

• Registration Number: NCT06570473
• Lead Sponsor: University of Alberta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age = 18 years.<br><br> 2. Able to provide informed consent.<br><br> 3. Able to comply with all study procedures.<br><br> 4. History of RV dysfunction or RHF secondary to any of:<br><br> a. Group 1 PH, pulmonary arterial hypertension b. Group 2 PH, left heart disease<br> with normal left ventricular ejection fraction (LVEF) > 50% and a previous RHC<br> demonstrating combined pre and post-capillary PH, defined as: i. mPAP >20 mmHg ii.<br> PAWP > 15 mmHg iii. PVR> 2 WU c. Group 3 PH d. Group 4 PH, chronic thromboembolic PH<br> that is either persistent after pulmonary endarterectomy or inoperable due to distal<br> disease.<br><br> 5. Symptomatic with current NYHA Functional Class II-IV<br><br> 6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:<br><br> 1. NT-proBNP >300 ng/L and qualitative evidence of at least 'mild' RV dysfunction<br> on echocardiography OR NT-proBNP<300 ng/L and qualitative evidence of at least<br> moderate RV dysfunction and/or dilatation on 2D echocardiogram AND<br><br> 2. A quantitative 2D echocardiogram with evidence of RV dysfunction defined as<br> having both of the following:<br><br> i. TAPSE =18 mm ii. RV dilatation (RV diameter > 42 mm at the base).<br><br> 7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4<br> weeks.<br><br> 8. Access to an iOS or android smart phone or tablet.<br><br>Exclusion Criteria:<br><br> 1. Estimated glomerular filtration rate (eGFR) <30 ml/min.<br><br> 2. LVEF < 50%<br><br> 3. Normal RV size and function<br><br> 4. Severe aortic or mitral valvular disease<br><br> 5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)<br><br> 6. Participants requiring augmentation of diuretics or otherwise not meeting definition<br> for clinical stability<br><br> 7. Pregnancy or lactation<br><br> 8. Unable to provide consent and comply with follow-up visits<br><br> 9. Listed for lung, heart or heart/lung transplantation<br><br> 10. Myocardial infarction or acute coronary syndrome within 90 days of screening<br><br> 11. Enrolled in another interventional trial<br><br> 12. Planned cardiac or thoracic surgical intervention in the next 6 months.<br><br> 13. Known hypersensitivity to empagliflozin or ranolazine.<br><br> 14. Concurrent treatment with:<br><br> - strong inhibitors of Cytochrome P450 3A4 (CYP 3A4), (e.g., ketoconazole,<br> itraconazole, voriconazole, posaconazole, clarithromycin, nelfinavir,<br> ritonavir, indinavir, saquinavir and grapefruit juice)<br><br> - class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide) or class<br> III antiarrhythmics (e.g., sotalol, ibutilide, amiodarone, dronedarone)<br><br> - inducers of CYP 3A4 (e.g., rifampin, rifabutin, rifapentine, phenobarbital,<br> phenytoin, carbamazepine, and St. John's wort)<br><br> 15. Congenital long QT syndrome or a QTc interval >500 ms

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of eligible participants approached that consent;The proportion of participants who consent that are randomized;Average enrolment rate of participants per centre per month;Loss of follow up or death;Ability to capture data for secondary outcomes

Secondary Outcome Measures

Name	Time	Method
RV function;Natriuretic peptides;Hemodynamics;Exercise capacity measured virtually;Exercise capacity measured in-person;NYHA functional class;EmPHasis-10;KCCQ-12;EQ-5D-5L;Clinical event outcomes