Not recruiting

Study of empagliflozin to improve exercise capacity in patients with hypertrophic cardiomyopathy

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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 Hypertrophic Cardiomyopathy, a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. The research examines the effects of empagliflozin (Jardiance), a medication taken as film-coated tablets, on the physical capabilities of people with this heart condition.

The purpose of this research is to determine if taking empagliflozin tablets (10 mg daily) for twelve months can improve the ability to exercise in people with Hypertrophic Cardiomyopathy. During the study, participants will be divided into two groups - one group will receive empagliflozin while the other will receive a placebo.

The medication being tested, empagliflozin, is already approved for other medical conditions. The study will last for twelve months, during which participants will need to take one tablet daily. Throughout the study, doctors will monitor how well participants can exercise and how their heart condition responds to the treatment.

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 visit and medication start
After joining the study, you will receive either empagliflozin (10 mg tablets) or a placebo tablet to take once daily
The tablet should be taken by mouth each day for 12 months
Neither you nor your doctor will know whether you are receiving the actual medication or placebo
Step 2
Exercise capacity test - beginning
You will undergo an exercise test to measure your VO2 max (maximum oxygen consumption during exercise)
You will also complete the KCCQ-OS questionnaire about your heart condition symptoms and quality of life
Step 3
Regular follow-up period
Continue taking one tablet daily for 12 months
Attend scheduled check-ups as determined by your healthcare team
Step 4
Final assessment - after 12 months
Repeat the exercise test to measure your VO2 max
Complete the final KCCQ-OS questionnaire
Final evaluation of your heart condition and overall health status
Step 5
Study completion
The study will end after completing all assessments
Your participation will help evaluate if empagliflozin improves exercise capacity in patients with hypertrophic cardiomyopathy (a condition where heart muscle becomes thickened)

Who can join the trial?

6 criteria

Patient must provide written voluntary consent to participate in the study
Patient must have a confirmed diagnosis of hypertrophic cardiomyopathy (a condition where heart muscle becomes thickened)
Patient must be 18 years of age or older
Both male and female patients can participate in the study
Patient must be able to take empagliflozin (a medication) at a dose of 10 mg daily for 12 months
Patient must be willing to participate in exercise capacity testing (tests that measure how well you can perform physical activity)

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of heart failure (when heart cannot pump blood effectively)
Previous myocardial infarction (heart attack)
Uncontrolled diabetes (blood sugar levels that are not well managed)
Severe kidney disease (poor kidney function)
Known allergies to empagliflozin or similar medications
Current participation in other clinical trials
History of stroke or mini-stroke in the past 6 months
Severe liver disease
Low blood pressure (systolic pressure below 90 mmHg)
History of alcohol or drug abuse
Mental conditions that could affect ability to follow study procedures
Any severe illness that could interfere with study participation
Use of medications that could interact with the study drug

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Verified sites

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Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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Warsaw, Poland

Trial locations

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Investigated drugs

Empagliflozin is a medication used to treat type 2 diabetes and heart failure. In this trial, it is being studied for patients with hypertrophic cardiomyopathy (a condition where the heart muscle becomes abnormally thick). The medication works by helping the kidneys remove excess sugar from the blood and has shown beneficial effects on heart function. It can help improve the heart's ability to pump blood and may reduce symptoms related to heart problems.

Empagliflozin

What is already known about the treatment

Empagliflozin - An oral medication taken once daily that belongs to the class of SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors). Originally approved for type 2 diabetes treatment, it is now being studied for its potential benefits in treating hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. The medication works by blocking glucose reabsorption in the kidneys, leading to increased glucose excretion in urine, but it also has beneficial effects on heart function and structure. Clinical trials are investigating its ability to improve exercise capacity in patients with hypertrophic cardiomyopathy, suggesting a potential expansion of its therapeutic applications in cardiovascular medicine.

Investigated diseases

Hypertrophic Cardiomyopathy - A genetic heart condition where the heart muscle becomes abnormally thick, particularly affecting the left ventricle. The thickened heart muscle can make it harder for the heart to pump blood efficiently. This condition can develop at any age and affects men and women equally. The thickening most commonly occurs in the wall between the two ventricles of the heart. People with this condition may experience shortness of breath during physical activity, chest pain, or palpitations.