Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomized in a 1:1 ratio into two arms: empagliflozin 10 mg or matching placebo orally daily for 6 months."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether empagliflozin helps the right side of the heart pump better in adults with pulmonary arterial hypertension (PAH), or high blood pressure in the lung arteries. It compares empagliflozin with a placebo, a pill with no active drug, in people taking stable doses of PAH medicines.
Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with group 1 PAH of a type allowed by the study. PAH must have been confirmed within the past 5 years by a test using a thin tube placed in the heart.
- Have weak pumping on the right side of the heart, shown by an ultrasound at screening. The study uses a measure called FAC of 40% or less; results from 35% to 40% need other signs of heart problems.
- Take approved PAH medicines at stable doses for at least 8 weeks, or 24 weeks for sotatercept, with no plans to change them.
- Have stable doses of diuretics, or water pills, for at least 4 weeks before screening.
- Sign a consent form, read and write English, and be willing and able to follow study steps for the full study.
- Be able to take medicine by mouth and agree to take the study drug as directed.
- If able to become pregnant, use highly effective birth control for at least 4 weeks before screening, throughout the study, and for 2 weeks after the last study drug dose.
- Be able to have heart MRI scans at the start and at week 24, under the study's imaging rules.
Who can't join
- Currently take insulin, sulfonylureas or meglitinides (medicines that help the body release insulin), lithium, or an SGLT2 inhibitor, the drug class that includes empagliflozin. Use of an SGLT2 inhibitor in the past 3 months also excludes you.
- Have been unable to tolerate an SGLT2 inhibitor, or have an allergy to empagliflozin or another drug in this class.
- Have type 1 diabetes, a history of diabetic ketoacidosis (dangerous acid buildup in the blood), or an HbA1c blood sugar result above 10% with symptoms such as frequent urination and strong thirst.
- Have too little fluid in the body, or right-sided heart failure that is no longer under control, as judged by the study doctor.
- Have very low kidney filtering function (eGFR below 30) or need treatment to replace kidney function, such as dialysis.
- Are pregnant or breastfeeding, or had more than one bacterial or yeast infection of the urinary tract or genitals in the past year.
- Have ongoing alcohol or drug abuse.
- Take another experimental drug now or took one in the past 4 weeks, or are enrolled in another trial that randomly assigns treatments. Studies that only observe people are allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * In order to be eligible to participate in this study, an individual must meet all the following criteria: 1. Provision of signed and dated informed consent form 2. Ability and stated willingness to comply with all study procedures and availability for the duration of the study 3. Ability to read and write in English 4. 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 unrepaired defects) according to the current guidelines and adjudicated by the local PI 5. PAH confirmed by right heart catheterization in the last 5 years 6. 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; group 1 PAH patients with an FAC ≤ 40% (mean 27.0 ± 8.0%) had a mean RV ejection fraction of 35.5 ± 11.3% CMR RV ejection fraction ≤ 54% classifies PAH as intermediate (37-54%) or high (\<37%) risk under current guidelines. However, to ensure we recruit patients with significantly impaired RV function, patients with RV FAC between 35.0-40.0% on the screening echocardiogram will have to meet at least one of the following additional criteria: a) TAPSE/sPAP ratio \< 0.31 mm/mmHg; b) elevated right atrial pressure defined as inferior vena cava (IVC) \> 2.1 cm in diameter and the IVC does not collapse with sniff/respiration; c) RV enlargement defined as RV basal diameter ≥ 4.1 cm; d) RV free wall longitudinal strain ≥ -22%; e) Interventricular septal flattening; and f) RV outflow tract mid or late systolic notching. 7. 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 clinical plans to change this therapy. 8. 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. 9. Ability to take oral medication and willingness to adhere to the study drug regimen. 10. 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 end of study drug administration 11. Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor 2. Use of an SGLT2 inhibitor within the past 3 months prior to screening 3. Prior documented inability to tolerate an SGLT2 inhibitor 4. Volume depletion, as ascertained by the site PI, at screening or baseline 5. History of diabetic ketoacidosis or type 1 diabetes mellitus 6. Chronic alcohol or drug abuse 7. More than one bacterial or yeast genitourinary tract infection in the year prior to enrollment 8. Estimated glomerular filtration rate under 30 mL/minute/1.73m2 or on renal replacement therapy 9. Pregnancy or lactation 10. Known allergy or hypersensitivity to empagliflozin or another SGLT-2 inhibitor 11. Currently taking or has taken another investigational drug within the past 4 weeks 12. Enrollment in another randomized intervention trial. (Participants participating in observational trials will not be excluded). 13. Decompensated right heart failure, as adjudicated by the site PI. 14. Screening HbA1c \>10% with symptoms such as polyuria and polydipsia
Study sites (3)
MD
- The Johns Hopkins Hospital · Baltimore, MD 21287Stephen Mathai, MD · Study contact · smathai4@jhmi.eduMore trials in Baltimore
OH
- Cleveland Clinic · Cleveland, OH 44195Gustavo Heresi, MD · Study contact · heresig@ccf.orgMore trials in Cleveland
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Anna Hemnes, MD · Study contact · anna.r.hemnes@vumc.orgMore trials in Nashville