Status:

RECRUITING

Feasibility Trial for a Right Ventricular Failure Platform Trial

Lead Sponsor:

University of Alberta

Collaborating Sponsors:

Canadian Heart Function Alliance

Accelerating Clinical Trials Consortium

Conditions:

Pulmonary Hypertension

Right Ventricular Dysfunction

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 hyperte...

Detailed Description

This study is an investigator-initiated, open label, prospective, multi-centre, phase 2, randomized control trial. This CRAVE feasibility trial will seek to establish the feasibility of a larger platf...

Eligibility Criteria

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

Key Trial Info

Start Date :

July 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06570473

Start Date

July 15 2025

End Date

December 1 2026

Last Update

September 18 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

University of Calgary

Calgary, Alberta, Canada, T1Y 6J4

2

University of Alberta

Edmonton, Alberta, Canada, T6G 2G3

3

The University of British Columbia

Vancouver, British Columbia, Canada, V5Z 1M9

4

London Health Sciences Centre - University Hospital

London, Ontario, Canada, N6A 5A5

Feasibility Trial for a Right Ventricular Failure Platform Trial | DecenTrialz