RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Empagliflozin 10 MG for Pulmonary Arterial Hypertension

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

Official registry: https://clinicaltrials.gov/study/NCT06992440 · Gustavo A Heresi, MD, MS · enrollment listed as 78

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empagliflozin 10 MG, or Placebo. The registry lists allocation as randomized. Randomly assigned, triple-masked, parallel arm clinical trial of empagliflozin versus dummy treatment (placebo) in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.

They plan to enroll about 78 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension

Interventions: Empagliflozin 10 MG, Placebo

Primary outcome (registry wording): Change in RV ejection fraction measured by CMR

Who it is for (from inclusion criteria)

Ages 18 Years to any
In order to be eligible to participate in this study, an individual must meet all the following criteria:
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
PAH confirmed by right heart catheterization in the last 5 years
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
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

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
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

Public study contact (from the registry)

Gustavo Heresi, MD

216 636-5327

HERESIG@ccf.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

The Johns Hopkins Hospital — Baltimore, Maryland (recruiting)
Cleveland Clinic — Cleveland, Ohio (recruiting)
Vanderbilt University Medical Center — Nashville, Tennessee (recruiting)

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FAQ about this NCT record

Is NCT06992440 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06992440?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06992440?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary