Empagliflozin for Pulmonary Arterial Hypertension

(EmPATH Trial)

Recruiting at 2 trial locations

Overseen By Erica Corrao, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gustavo A Heresi, MD, MS

Must be taking: PAH-targeted therapy

Must not be taking: Insulin, SGLT2 inhibitors

Disqualifiers: Type 1 diabetes, Renal failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

78 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.

Research Team

Gustavo Heresi, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for individuals with Pulmonary Arterial Hypertension (PAH) who are already on stable PAH-targeted medications. The specific eligibility criteria to join the study have not been provided, but typically include factors like age range, disease severity, and absence of certain health conditions.

Inclusion Criteria

PAH confirmed by right heart catheterization in the last 5 years

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

RV dysfunction defined FAC < 34.0% on echocardiography performed during the screening visit

Exclusion Criteria

Decompensated right heart failure, as adjudicated by the site PI

I have not taken SGLT2 inhibitors in the last 3 months.

I have a history of diabetic ketoacidosis or type 1 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either empagliflozin 10 mg or placebo orally once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin

Trial Overview The trial is testing Empagliflozin, a medication that could potentially improve heart function in PAH patients. Participants will be randomly assigned to either receive Empagliflozin or a placebo without knowing which one they're getting (triple-masked). They'll continue their current PAH treatments during the trial.

Participant Groups

Group I: Empagliflozin Active Control 1 Intervention

Participants receive Empagliflozin 10 mg orally once daily for 24 weeks. Empagliflozin is over-encapsulated to match placebo.

Group II: Placebo Placebo Group 1 Intervention

Participants receive placebo tablet over-encapsulated to match Empagliflozin orally once daily for 24 weeks.

Who Is Running the Clinical Trial?

Gustavo A Heresi, MD, MS

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+