Pulmonary Arterial Hypertension study: Empagliflozin
Official title Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT06992440
What this study is testing
What is Empagliflozin 10 MG?
An investigational oral tablet being studied as a potential treatment for pulmonary arterial hypertension. It is designed to block the sodium‑glucose co‑transporter‑2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion.
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
- This study aims to find out if taking empagliflozin improves how well the right ventricle (the heart's right pumping chamber) functions.
- Who it's for
- The study is looking for people with pulmonary arterial hypertension who are already taking standard, stable treatment for this condition.
- What's involved
- Participants will be randomly assigned to take either empagliflozin or a placebo (a pill with no active medicine) while continuing their usual heart medications.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Provision of signed and dated informed consent form
- Ability and stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to read and write in English
- Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue...
- PAH confirmed by right heart catheterization in the last 5 years
You likely can't join if
- Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor
- Use of an SGLT2 inhibitor within the past 3 months prior to screening
- Prior documented inability to tolerate an SGLT2 inhibitor
- Volume depletion, as ascertained by the site PI, at screening or baseline
- History of diabetic ketoacidosis or type 1 diabetes mellitus
- Chronic alcohol or drug abuse
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Ability and stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to read and write in English
- Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue disease and with congenital heart disease (simple repaired or...
- PAH confirmed by right heart catheterization in the last 5 years
- RV dysfunction defined as FAC ≤ 40.0% on echocardiography performed during the screening visit. In PVDOMICS, FAC has a strong correlation with CMR RV ejection fraction
- On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no...
- Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician.
- Ability to take oral medication and willingness to adhere to the study drug regimen.
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the...
- Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI
- Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor
- Use of an SGLT2 inhibitor within the past 3 months prior to screening
- Prior documented inability to tolerate an SGLT2 inhibitor
- Volume depletion, as ascertained by the site PI, at screening or baseline
- History of diabetic ketoacidosis or type 1 diabetes mellitus
- Chronic alcohol or drug abuse
- More than one bacterial or yeast genitourinary tract infection in the year prior to enrollment
- Estimated glomerular filtration rate under 30 mL/minute/1.73m2 or on renal replacement therapy
- Pregnancy or lactation
- Known allergy or hypersensitivity to empagliflozin or another SGLT-2 inhibitor
- Currently taking or has taken another investigational drug within the past 4 weeks
- Enrollment in another assigned by chance intervention trial. (Participants participating in observational trials will not be excluded).
- Decompensated right heart failure, as adjudicated by the site PI.
- Screening HbA1c \>10% with symptoms such as polyuria and polydipsia
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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?
This study is enrolling now at Baltimore, Maryland, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.