Feasibility assessment of treatments for right ventricular failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the feasibility of a larger platform trial focused on improving right ventricular function in patients with pulmonary hypertension and right heart failure. It involves a randomized control design with 30 participants who will receive either empagliflozin or ranolazine in addition to standard care, or standard care alone. The study will follow participants for 16 weeks to assess outcomes related to their condition. The goal is to determine if these treatments can be effectively tested in a larger study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Able to provide informed consent.
3. Able to comply with all study procedures.
4. History of RV dysfunction or RHF secondary to any of:

   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.
5. Symptomatic with current NYHA Functional Class II-IV
6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:

   1. NT-proBNP \>300 ng/L and qualitative evidence of at least 'mild' RV dysfunction on echocardiography OR NT-proBNP\<300 ng/L and qualitative evidence of at least moderate RV dysfunction and/or dilatation on 2D echocardiogram AND
   2. A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following:

   i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \> 42 mm at the base).
7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.
8. Access to an iOS or android smart phone or tablet.

Exclusion Criteria:

1. Estimated glomerular filtration rate (eGFR) \<30 ml/min.
2. LVEF \< 50%
3. Normal RV size and function
4. Severe aortic or mitral valvular disease
5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
6. Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability
7. Pregnancy or lactation
8. Unable to provide consent and comply with follow-up visits
9. Listed for lung, heart or heart/lung transplantation
10. Myocardial infarction or acute coronary syndrome within 90 days of screening
11. Enrolled in another interventional trial
12. Planned cardiac or thoracic surgical intervention in the next 6 months.
13. Known hypersensitivity to empagliflozin or ranolazine.
14. Concurrent treatment with:

    * strong inhibitors of Cytochrome P450 3A4 (CYP 3A4), (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, nelfinavir, ritonavir, indinavir, saquinavir and grapefruit juice)
    * class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmics (e.g., sotalol, ibutilide, amiodarone, dronedarone)
    * inducers of CYP 3A4 (e.g., rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
15. Congenital long QT syndrome or a QTc interval \>500 ms

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting
• University of Calgary
  Calgary, Alberta, Canada Not yet recruiting
• The University of British Columbia
  Vancouver, British Columbia, Canada Not yet recruiting
• London Health Sciences Centre - University Hospital
  London, Ontario, Canada Not yet recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Jason Weatherald, MD,MSc,FRCPC — University of Alberta
• Study coordinator: Jason Weatherald, MD,MSc,FRCPC
• Email: weathera@ualberta.ca
• Phone: 780-492-9937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.