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Feasibility Trial for a Right Ventricular Failure Platform Trial

ConditionsPulmonary HypertensionRight Ventricular DysfunctionRight Heart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Able to provide informed consent.

Able to comply with all study procedures.

Symptomatic with current NYHA Functional Class II-IV

Disqualifiers

Estimated glomerular filtration rate (eGFR) <30 ml/min.

LVEF < 50%

Normal RV size and function

Severe aortic or mitral valvular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin

    Drug

    Tablet

  • Ranolazine

    Drug

    Tablet

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: EmpagliflozinExperimental treatment 1 intervention
Group B: RanolazineExperimental treatment 1 intervention
Group C: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of eligible participants approached that consent

(target ≥30%)

Time frame
16 weeks
2

The proportion of participants who consent that are randomized

(target ≥90%)

Time frame
16 weeks
3

Average enrolment rate of participants per centre per month

(target ≥1 participant per centre/month)

Time frame
16 weeks
4

Loss of follow up or death

Loss of follow up (target at 16 weeks ≤5%)

Time frame
16 weeks

Secondary outcomes

1

RV function

assessed using echocardiogram

Time frame
16 weeks
2

Natriuretic peptides

(N-terminal pro-B-type natriuretic peptide \[NT-proBNP\])

Time frame
16 weeks
3

Hemodynamics

assessed using right heart catheterization (RHC)

Time frame
16 weeks
4

Exercise capacity measured virtually

6-minute walk distance (6MWD) assessed using the novel Walk.Talk.Track. mobile app

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Canadian Heart Function Alliance

Collaborator

Accelerating Clinical Trials Consortium

Collaborator

Ottawa Heart Institute Research Corporation

Collaborator

Team PHenomenal Hope

Collaborator

Source ClinicalTrials.gov
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