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

3 1 1

What is this study about?

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.

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

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

3 Regular follow-up period

Continue taking one tablet daily for 12 months

Attend scheduled check-ups as determined by your healthcare team

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Mbazeht Ughipoxytz Oj Bzxwywuhz Bialystok Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.03.2023

Trial locations

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.

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.

Trial ID:
2024-517643-31-00
Protocol code:
EMPA-REPAIR-HCM
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study testing ninerafaxstat compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy

    Recruiting

    2 1
    Austria Belgium France Germany Italy The Netherlands +3
  • Comparing hydrochlorothiazide and valsartan for treating high blood pressure in patients with hypertrophic obstructive cardiomyopathy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Austria