# Master - 2/2 Empaglifozin To Improve Right Ventricular Function in Pulmonary Arterial Hypertension

> **NIH NIH U24** · CLEVELAND CLINIC LERNER COM-CWRU · 2024 · $371,492

## Abstract

DCC Project Summary Abstract
Despite advances in medical therapy for pulmonary arterial hypertension (PAH), mortality rates remain high.
Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension (EmPAH) is a 3-center
blinded, placebo-controlled, randomized Phase II trial testing whether 10 mg empagliflozin taken daily for 24
weeks will improve PAH patient heart function and other outcomes. The trial's primary endpoint is change in
Right Ventricular Ejection Fraction measured by Cardiac Magnetic Resonance (CMR) imaging. Secondary
endpoints include: changes in Tricuspid Annular Plane Systolic Excursion (TAPSE) measured by echocardio-
gram, 6 Minute Walk Distance, quality of life (SF-36 Physical Health Composite and EmPHAsis10), and N-
terminal pro B-type natriuretic peptide (NT-proBNP), each measured at baseline, weeks 12, week 24; a “time
to clinical worsening” composite, defined multicomponent improvement, and proportion of patients meeting
the three criteria of the French Risk Score. Seven additional exploratory endpoints have been specified,
and the Data Coordinating Center (DCC) will also carry out exploratory analyses of clinical and cardiac
imaging phenotypes associated with response to empagliflozin therapy. The DCC will oversee study
design and carry out all statistical analyses and contribute to EmPAH publications and dissemination. The
DCC will play a leadership role in the development of the trial protocol, manual of operations, and case
report forms, and will monitor recruitment, retention, adherence, and especially safety, as well as track and
implement procedures to improve the quality of data, samples, and images. The DCC will prepare DSMB
reports and manage virtual DSMB meetings and as well as the annual DSMB meetings in Bethesda. DCC
statistical, database, and administrative personnel will ensure the trial fully exemplifies regulatory compliance
and best practices for data collection and database management. The Biorepository - a section of the DCC -
will train sites in biological sample collection, local storage, and monthly shipment to the Biorepository which
will analyze triglycerides, LDL, HDL, total cholesterol and NT-proBNP and will archive samples for sharing.
Echocardiograms and CMR images will be read centrally at the Imaging Center – a section of the CCC – who
will train sites to collect appropriately-formatted images following EmPAH procedures, securely transfer images
to the CMR and Echo Core labs and will transmit results to the DCC. The DCC will develop and maintain the
trial's distributed data entry and database management systems. Triple blinding of randomized treatment
(empagliflozin vs. placebo) will reduce the potential for bias due to knowledge of treatment, even at the
subconscious level, among participants, investigators, health care providers, outcome measurers, and
biostatisticians. EmPAH's Phase II trial sample size of 78 has 85% power to show a difference of 11
percentage poin...

## Key facts

- **NIH application ID:** 10948583
- **Project number:** 1U24HL175028-01
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** JENNIFER J GASSMAN
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $371,492
- **Award type:** 1
- **Project period:** 2024-09-01 → 2030-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10948583

## Citation

> US National Institutes of Health, RePORTER application 10948583, Master - 2/2 Empaglifozin To Improve Right Ventricular Function in Pulmonary Arterial Hypertension (1U24HL175028-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10948583. Licensed CC0.

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