Study of Empagliflozin to Improve Heart Function in Adults with Pulmonary Arterial Hypertension

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What is this study about?

This study focuses on patients with Pulmonary Arterial Hypertension (PAH), a condition where blood pressure in the arteries of the lungs is abnormally high, making it harder for the heart to pump blood through the lungs. The study will test a medication called Empagliflozin, which belongs to a group of medicines known as SGLT-2 inhibitors, compared to a placebo.

The purpose of this research is to evaluate how the heart’s right chamber functions and whether it improves after treatment with Empagliflozin in people with PAH. During the study, participants will receive either Empagliflozin capsules or placebo capsules to take by mouth. The treatment period will last for 4 weeks, with a daily dose of 10 milligrams of Empagliflozin for those in the treatment group.

Throughout the study, various tests will be performed to monitor heart function, including heart imaging tests and measurements of blood flow in the lungs. The study will also track how well participants can exercise, their breathing capacity, and how they feel during daily activities. Participants will continue their regular PAH medications while participating in this study.

1 Initial treatment phase start

You will receive either empagliflozin capsules or placebo capsules (inactive substance) to take by mouth

The treatment will continue for 4 weeks

You must take the medication as prescribed while continuing your current pulmonary arterial hypertension (PAH) treatments

2 Initial measurements

Medical staff will perform an echocardiogram (heart ultrasound) to check your heart function

You will undergo a cardiac MRI scan to obtain detailed images of your heart

A Swan-Ganz catheterization procedure will be performed to measure blood pressure in your heart and lungs

3 Physical capacity tests

You will complete a six-minute walking test to measure your exercise capacity

A breathing test will be performed to check your lung function

Blood samples will be taken to measure oxygen levels and other important values

4 Quality of life assessment

You will be asked to complete questionnaires about your symptoms and daily activities

The medical team will evaluate your physical condition using the WHO Functional Class scale

5 Final evaluation

After 4 weeks, all initial tests will be repeated to measure any changes

The medical team will document any side effects or health changes during the study period

Who Can Join the Study?

Age 18 or older
Body Mass Index (BMI) must be greater than 18 kg/m2 (BMI is a measure of body fat based on height and weight)
Must have Pulmonary Arterial Hypertension (PAH) that falls into one of these categories:
- Idiopathic (occurring without known cause)
- Heritable (inherited)
- Caused by drugs or toxins
- Associated with connective tissue disease
- Associated with repaired heart defects (must be repaired at least 1 year before screening)
- Associated with stable HIV infection
Must be in WHO Functional Class II or III (classification of symptom severity)
Must meet specific heart measurements during screening:
- Mean pulmonary artery pressure above 20 mmHg
- Pulmonary vascular resistance at or above 240 dyne•sec/cm5
- Pulmonary capillary wedge pressure at or below 15 mmHg
Must be on stable PAH treatment for at least 12 weeks, with no dose changes for at least 8 weeks before screening
For women who can become pregnant:
- Must have a negative pregnancy test
- Must agree to use effective birth control during the study and for 30 days after
Must provide written informed consent

Who Cannot Join the Study?

Age below 18 years or above 75 years
Current pregnancy or breastfeeding
History of allergic reactions to Empagliflozin or similar medications
Severe kidney disease (as measured by estimated glomerular filtration rate below 30 mL/min)
Type 1 diabetes
Severe liver disease
Recent heart attack or stroke (within past 3 months)
Uncontrolled high blood pressure (blood pressure above 160/100 mmHg)
Active urinary tract infection
Currently participating in another clinical trial
Unable to provide informed consent
History of recurrent urinary tract infections (more than 3 in past year)
Low blood pressure (systolic blood pressure below 90 mmHg)
Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Kutfhxrb dfc Uywnqsnylrlh Maftxcol Anz	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Empagliflozin

Empagliflozin is a medication that belongs to a class of drugs called SGLT2 inhibitors. It was originally developed to treat type 2 diabetes by helping remove excess sugar from the body through urination. In this trial, researchers are studying how this medication might help patients with pulmonary arterial hypertension (PAH), specifically focusing on its potential benefits for improving the function of the right side of the heart. The medication is taken orally in the form of tablets.

Pulmonary arterial hypertension – A progressive condition where blood pressure in the arteries of the lungs becomes abnormally high. This increased pressure occurs when the tiny arteries in the lungs become narrowed, thickened, or stiff, making it harder for blood to flow through them. As a result, the heart needs to work harder to pump blood through these vessels. Over time, this extra strain causes changes in the heart’s right ventricle, making it gradually enlarge and become less efficient at pumping. The condition typically causes symptoms such as shortness of breath during routine activities, fatigue, chest pain, and dizziness.

Trial ID:

2024-517009-99-00

Protocol code:

KKS-323

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Empagliflozin to Improve Heart Function in Adults with Pulmonary Arterial Hypertension

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?