BridgeMD
New treatment option for Pulmonary Hypertension
Official title Feasibility Trial for a Right Ventricular Failure Platform Trial
ClinicalTrials.gov ID: NCT06570473
What this study is testing
What is Empagliflozin?
Empagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary hypertension.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Able to provide informed consent.
- Able to comply with all study procedures.
- 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...
- Symptomatic with current NYHA Functional Class II-IV
You likely can't join if
- Estimated glomerular filtration rate (eGFR) \<30 ml/min.
- LVEF \< 50%
- Normal RV size and function
- Severe aortic or mitral valvular disease
- Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
- Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability
See the full eligibility criteria
- Age ≥ 18 years.
- Able to provide informed consent.
- Able to comply with all study procedures.
- 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...
- Symptomatic with current NYHA Functional Class II-IV
- Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:
- 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...
- 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).
- Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.
- Access to an iOS or android smart phone or tablet.
- Estimated glomerular filtration rate (eGFR) \<30 ml/min.
- LVEF \< 50%
- Normal RV size and function
- Severe aortic or mitral valvular disease
- Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)
- Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability
- Pregnancy or lactation
- Unable to provide consent and comply with follow-up visits
- Listed for lung, heart or heart/lung transplantation
- Myocardial infarction or acute coronary syndrome within 90 days of screening
- Enrolled in another treatment trial
- Planned cardiac or thoracic surgical intervention in the next 6 months.
- Known hypersensitivity to empagliflozin or ranolazine.
- 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)
- Congenital long QT syndrome or a QTc interval \>500 ms
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.