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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

16 criteria

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 trial?

14 criteria

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

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Verified sites

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Justus-Liebig-Universitaet Giessen
Giessen, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

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Investigated drugs

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.

Empagliflozin

What is already known about the treatment

Empagliflozin - An oral medication belonging to the class of sodium-glucose cotransporter-2 (SGLT2) inhibitors, traditionally used for type 2 diabetes treatment but now being investigated for pulmonary arterial hypertension (PAH). The drug works by blocking glucose reabsorption in the kidneys, leading to increased glucose excretion in urine, and is being studied for its potential effects on improving right ventricular function in PAH patients. This medication is administered as a tablet taken once daily, and research suggests it may have beneficial effects on heart function beyond its glucose-lowering properties, making it a promising candidate for PAH treatment in clinical trials.

Investigated diseases

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.