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Hypertrophic cardiomyopathy – Trials in Disease

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Ongoing Clinical Trials for Hypertrophic Cardiomyopathy

Currently, there are 13 ongoing clinical trials investigating various treatments for hypertrophic cardiomyopathy, a genetic heart condition where the heart muscle becomes abnormally thick. These studies are testing medications including cardiac myosin inhibitors, SGLT inhibitors, beta-blockers, and other drugs, as well as catheter ablation procedures. The trials are being conducted across multiple European countries and involve both adults and adolescents with different forms of the condition.

Clinical trial locations

Study on Sotagliflozin for Improving Symptoms in Patients with Hypertrophic Cardiomyopathy

This trial is investigating sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, for treating both obstructive and non-obstructive forms of the condition. The study aims to evaluate whether this medication can improve symptoms and quality of life in affected patients.

Who can participate: Adults diagnosed with either obstructive or non-obstructive forms of the condition who experience symptoms classified as New York Heart Association class II or higher. Participants must have a KCCQ Clinical Summary Score below 85, indicating some impact on daily life from heart failure symptoms. The heart muscle must show thickening of at least 15 mm, or 13 mm if there is a family history. Participants should be on stable doses of any current heart medications for at least one month before joining.

Who cannot participate: People with other serious heart conditions unrelated to this specific diagnosis, those who recently experienced a heart attack, individuals with uncontrolled high blood pressure, people with severe kidney problems, pregnant or breastfeeding women, those currently using medications that might interfere with the study treatment, people with a history of severe allergic reactions to similar medications, those with active infections requiring treatment, individuals with drug or alcohol abuse history in the past year, and those who participated in another clinical trial within the last 30 days.

Main focus: The study will run for 26 weeks during which participants will be randomly assigned to receive either sotagliflozin tablets or a placebo. Regular assessments will include questionnaires about symptoms and echocardiograms to measure changes in heart function. The primary goal is to determine if sotagliflozin can improve the Kansas City Cardiomyopathy Questionnaire scores and reduce symptoms.

Medication being tested: Sotagliflozin is administered as an oral film-coated tablet. It works by inhibiting proteins involved in glucose reabsorption in the kidneys, which may also benefit heart function in people with this condition.

Study on the Effects of Bisoprolol and Verapamil in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

This Danish study examines the effects of two commonly used heart medications, bisoprolol and verapamil, in patients with the non-obstructive form of the condition. The research aims to understand how these medications affect heart function and symptom severity over three months.

Who can participate: Adults aged 18 years or older with a heart wall thickness of 15 mm or more that is not caused by high blood pressure, valve diseases, or storage diseases. Participants must meet at least one of these criteria: experience symptoms classified as NYHA class II or higher, have a history of such symptoms before starting beta-blockers or calcium channel blockers, have Pro-BNP levels greater than 300 ng/l or BNP levels greater than 100 ng/l, or have experienced episodes of fast heart rhythm with rates exceeding 120 beats per minute lasting at least 3 cycles, documented within the last 2 years. Both male and female participants are eligible.

Who cannot participate: People with other types of heart conditions not related to non-obstructive form, individuals outside the specified age range, those who cannot safely take the study medications, people with certain medical conditions that might interfere with the study or make it unsafe, and individuals who are part of a vulnerable population.

Main focus: The study will monitor changes in maximum oxygen consumption, left ventricular end-diastolic volume, and the occurrence of non-sustained ventricular tachycardia. Participants will receive either bisoprolol, verapamil, or a placebo, with regular monitoring throughout the three-month period. Additional assessments include questionnaires and various cardiac tests such as echocardiography and ambulatory ECG monitoring.

Medications being tested: Bisoprolol is a beta-blocker that slows heart rate and reduces the heart’s workload. Verapamil is a calcium channel blocker that helps relax heart muscles and blood vessels. Both medications are administered orally.

Study on the Long-Term Safety of Aficamten (CK-3773274) for Patients with Symptomatic Hypertrophic Cardiomyopathy

This long-term safety study evaluates aficamten, a cardiac myosin inhibitor, in patients who have symptoms of the condition. The trial focuses on gathering information about how well patients tolerate the medication over an extended period and monitoring any potential side effects.

Who can participate: Patients who have completed a previous study involving aficamten (CK-3773274) within 90 days of enrollment are eligible. Participants must have a left ventricular ejection fraction of 55% or higher, which measures how well the heart pumps blood. Male patients must agree to use contraception and not donate sperm during the study and for at least 10 weeks after the last dose. Female patients must not be pregnant, breastfeeding, or planning to donate eggs, and must use highly effective birth control methods during the study and for 4 weeks after the last dose.

Who cannot participate: People with other serious heart conditions besides this specific diagnosis, those who had a heart attack or heart surgery in the past three months, individuals with uncontrolled high blood pressure, people with severe liver or kidney disease, pregnant or breastfeeding women, those participating in another clinical trial, people with a history of drug or alcohol abuse, and individuals with a known allergy to the study medication or any of its ingredients.

Main focus: The study monitors the long-term safety and tolerability of aficamten, with regular assessments to track any adverse events and measure heart function, specifically looking at the left ventricular ejection fraction and left ventricular outflow tract gradient at rest and during specific maneuvers. Follow-up evaluations occur at 12-week intervals.

Medication being tested: Aficamten is administered as oral film-coated tablets. It works by selectively inhibiting cardiac myosin, which helps reduce excessive heart muscle contraction, thereby improving heart function.

Study Evaluating Direct Oral Anticoagulants for Prevention of Blood Clots in Patients with Hypertrophic Cardiomyopathy and Abnormal Left Atrial Function

This French study examines whether using blood-thinning medication can prevent serious complications like stroke in patients who have abnormal left atrial function. The research compares direct oral anticoagulants with standard care.

Who can participate: Adults aged 18 to 80 years with normal heart rhythm (sinus rhythm) who have been previously diagnosed with primary form of the condition and have an abnormal left atrial reservoir strain measured at 20% or less. Participants must be willing and able to sign an informed consent form.

Who cannot participate: People who had a previous heart attack or stroke in the last 6 months, those with severe heart valve disease, individuals who have had a blood clot in their heart, people with diseases that cause increased risk of bleeding, those allergic to the study medication, individuals with severe liver or kidney disease, people currently participating in another clinical trial, pregnant or breastfeeding women, those with a history of non-compliance with medical treatments, and people with a life expectancy of less than 1 year due to other medical conditions.

Main focus: The study evaluates how well direct oral anticoagulants work in preventing serious events like stroke, heart attack, and blood clots traveling to other parts of the body. Participants will be randomly assigned to either receive the anticoagulant medication or standard management, with monitoring through various tests including ECG and Holter monitoring. The study will also assess quality of life using the Kansas City Cardiomyopathy Questionnaire.

Medications being tested: The study involves direct oral anticoagulants such as edoxaban and possibly aspirin, which help prevent blood clots by making platelets less sticky and blocking specific proteins in the blood involved in the clotting process.

Study of Aficamten for Children with Symptomatic Obstructive Hypertrophic Cardiomyopathy

This pediatric study evaluates aficamten in children and teenagers with the obstructive form of the condition. The trial consists of two parts: an initial 12-week period where participants receive either the medication or placebo, followed by an optional open-label extension where everyone receives the medication.

Who can participate: Young people aged 12 to 17 years who weigh at least 45 kg initially, and then at least 35 kg after the first group completes a specific study phase. Participants must have the obstructive form confirmed by heart ultrasound, including thickened heart muscle and a normal-sized heart chamber, with the heart’s pumping ability at least 60% and a specific heart pressure measurement of at least 50 mmHg. The condition must be of sarcomeric origin, confirmed by genetic testing when possible. Participants must have NYHA Class II or higher heart condition, meaning some limitations in physical activity. If taking certain heart medications, participants must have been on a stable dose for more than 4 weeks before starting the study.

Who cannot participate: People not within the specified age range, those unwilling or unable to follow study procedures, individuals with other medical conditions that might interfere with the study, those taking medications that might interfere, pregnant or breastfeeding individuals, those who participated in another clinical trial recently, people with a history of drug or alcohol abuse, and those with a known allergy to the study medication.

Main focus: The study evaluates changes in heart function, particularly in the left ventricular outflow tract, over the 12-week initial period. Participants will have regular check-ups including echocardiograms and other tests to measure the medication’s effect. Those completing the first part may enter an open-label extension phase with continued monitoring every 12 weeks.

Medication being tested: Aficamten is administered as a 5 mg oral tablet taken once daily. It works by reducing the force of heart muscle contractions, which helps improve blood flow and reduce symptoms.

Study on Early Ablation and Use of Amiodarone, Beta-Blockers, or Sotalol for Atrial Fibrillation in Patients with Hypertrophic Cardiomyopathy

This Polish study explores different strategies to prevent the recurrence of atrial fibrillation, a common complication in patients with this condition. The research compares an invasive procedure called ablation with two medication-based approaches.

Who can participate: Adults aged 18 years or older who have been diagnosed with the condition as defined by the European Society of Cardiology and have had documented episodes of atrial fibrillation lasting more than 30 seconds. Participants must have signed an informed consent form.

Who cannot participate: People with significant enlargement of the left atrium, individuals who cannot take certain heart medications due to other health issues, those who have already undergone percutaneous ablation for atrial fibrillation, people unable to follow study procedures or take required medications, individuals with other serious health conditions that might interfere with the study, pregnant or breastfeeding women, and those participating in another clinical trial simultaneously.

Main focus: The study compares three treatment strategies: early ablation, amiodarone medication, and beta-blockers or sotalol. The trial involves 725 patients in an observation phase, with 300 patients with documented atrial fibrillation continuing to the treatment phase. Participants are monitored for primary endpoints such as death, stroke, or unscheduled medical interventions, as well as secondary endpoints including atrial fibrillation load and quality of life changes. The study will run until March 2029.

Medications and procedures being tested: Amiodarone is used to treat and prevent irregular heartbeats. Beta-blockers help slow down heart rate and reduce blood pressure. Sotalol helps regulate heart rhythm. Ablation is a procedure using energy to create small scars in heart tissue to block abnormal electrical signals.

Study on Mavacamten for Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

This study evaluates mavacamten, a cardiac myosin inhibitor, for adults with the obstructive form of the condition. The trial uses cardiac magnetic resonance imaging to assess changes in heart structure over 96 weeks.

Who can participate: Adults with symptomatic obstructive form classified as NYHA Functional Class II or III. Both men and women are eligible, including those who are part of vulnerable populations.

Who cannot participate: People with other serious heart conditions besides the one being studied, those who had a heart attack in the past 6 months, individuals with uncontrolled high blood pressure, people with severe liver or kidney disease, pregnant or breastfeeding women, those currently participating in another clinical trial, people with a history of drug or alcohol abuse, individuals with an allergy to the study medication, those with a pacemaker or other implanted heart device, people who had heart surgery in the past 3 months, individuals with certain types of irregular heartbeats, and those unable to undergo MRI imaging due to medical reasons.

Main focus: The study aims to determine if mavacamten can reduce heart wall thickness and the size of the upper heart chamber. Participants receive either mavacamten or placebo in capsule form, with regular monitoring including cardiac magnetic resonance imaging. The primary assessment occurs at week 48 to evaluate changes in heart structure and improvements in heart failure class.

Medication being tested: Mavacamten is administered as oral capsules. It works by inhibiting cardiac myosin, a protein involved in heart muscle contraction, which helps reduce excessive contraction and improve heart function.

Long-term Safety Study of Mavacamten for Adults with Hypertrophic Cardiomyopathy from Previous Trials

This long-term safety study follows participants who have completed previous trials called MAVERICK-HCM and EXPLORER-HCM, which studied non-obstructive and obstructive forms respectively. The study monitors how well participants tolerate mavacamten over an extended period.

Who can participate: Adults who have completed one of the two previous studies within 90 days of signing consent. Participants must weigh more than 45 kg, have adequate heart imaging results, a left ventricular ejection fraction of 50% or higher, and lab test results within normal limits or deemed acceptable by the doctor. Female participants must not be pregnant or breastfeeding and must use effective birth control methods during the study and for 4 months after the last dose. For the sub-study component, patients must meet specific criteria and be enrolled in the MYK-461-007 Study.

Who cannot participate: People who have not been previously enrolled in one of the two specific placebo-controlled trials (MAVERICK-HCM or EXPLORER-HCM), those without a diagnosis of the condition, individuals not within the specified age range or clinical trial groups, and those not considered part of the vulnerable population selected for the study.

Main focus: The study assesses long-term safety and tolerability of mavacamten, monitoring for major cardiac events and hospitalizations. Participants undergo regular assessments including echocardiography and, for some, cardiac magnetic resonance imaging to evaluate changes in cardiac mass and structure over time.

Medication being tested: Mavacamten is administered as oral capsules with doses ranging from 2.5 mg to 15 mg. It is classified as a cardiac myosin inhibitor that works by reducing excessive heart muscle contraction.

Study Comparing Aficamten and Metoprolol for Adults with Symptomatic Hypertrophic Cardiomyopathy

This comparative study evaluates whether aficamten can improve exercise capacity better than metoprolol, a commonly used medication, in adults with the obstructive form of the condition.

Who can participate: Adults aged 18 to 85 years with a body mass index less than 35. Participants must be diagnosed with obstructive form using specific heart imaging tests, showing thickened heart muscle without other heart diseases and a certain thickness of the heart wall. They should have a KCCQ score of 90 or less and specific heart measurements from an echocardiogram including resting LVOT-G greater than 30 mm Hg or post-Valsalva LVOT-G of 50 mm Hg or more, plus left ventricular ejection fraction of 60% or higher. Hemoglobin level must be 10 g/dL or higher. Those who previously took mavacamten can join if they stopped at least 8 weeks before participating.

Who cannot participate: People with other serious heart conditions not related to obstructive form, those who had a heart attack or stroke in the past six months, individuals with uncontrolled high blood pressure, people with severe liver or kidney disease, pregnant or breastfeeding women, those currently participating in another clinical trial, people with a history of drug or alcohol abuse in the past year, and individuals deemed unsuitable by the study doctor.

Main focus: The 24-week study compares how aficamten and metoprolol affect exercise capacity, measured by peak oxygen uptake through cardiopulmonary exercise testing. Participants are randomly assigned to receive either aficamten tablets, metoprolol prolonged-release tablets, or placebo. Regular follow-up visits include repeat testing, KCCQ assessments, and echocardiographic measurements. The primary endpoint is the change in peak oxygen uptake from baseline to Week 24.

Medications being tested: Aficamten is administered as oral film-coated tablets and works by selectively inhibiting cardiac myosin to reduce excessive heart muscle contraction. Metoprolol is given as prolonged-release tablets and works by blocking beta-adrenergic receptors to decrease heart rate and the heart’s workload.

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

This Polish study investigates whether empagliflozin, an SGLT2 inhibitor originally approved for type 2 diabetes, can improve exercise capacity in patients with the condition over a twelve-month period.

Who can participate: Adults aged 18 years or older with a confirmed diagnosis of the condition who provide written voluntary consent. Participants must be able to take empagliflozin at a dose of 10 mg daily for 12 months and be willing to participate in exercise capacity testing. Both male and female patients can participate.

Who cannot participate: People below 18 years or above 65 years, pregnant or breastfeeding women, those with a history of heart failure, people who previously had a heart attack, individuals with uncontrolled diabetes, those with severe kidney or liver disease, people with known allergies to empagliflozin or similar medications, those currently participating in other clinical trials, individuals with a history of stroke or mini-stroke in the past 6 months, people with low blood pressure below 90 mmHg systolic, those with a history of alcohol or drug abuse, individuals with mental conditions that could affect their ability to follow study procedures, people with any severe illness that could interfere with study participation, and those using medications that could interact with the study drug.

Main focus: Participants receive either empagliflozin (10 mg tablets) or placebo once daily for twelve months. The study measures changes in VO2 max (maximum oxygen consumption during exercise) from the beginning to the end of the trial, along with KCCQ-OS questionnaire assessments about heart condition symptoms and quality of life.

Medication being tested: Empagliflozin is administered as oral film-coated tablets taken once daily. It belongs to the class of SGLT2 inhibitors and works by blocking glucose reabsorption in the kidneys, but also has beneficial effects on heart function and structure.

Study of Mavacamten for Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy

This study evaluates mavacamten in adolescents aged 12 to under 18 years with the obstructive form of the condition. The trial examines how the medication affects the heart’s ability to pump blood and reduce obstruction in young people.

Who can participate: Adolescents aged 12 to less than 18 years at the start of the study with a diagnosis of obstructive form confirmed by heart ultrasound. This includes having thickened heart muscle and a normal-sized heart chamber, without other heart diseases. The heart’s pumping ability must be at least 60%, and a specific heart pressure measurement must be at least 50 mmHg. Participants must have NYHA Class II or higher symptoms and adequate acoustic windows for echocardiography. If taking certain heart medications, participants must have been on a stable dose for more than 4 weeks before starting.

Who cannot participate: Those with other serious heart conditions besides this specific diagnosis, people who had recent heart surgery or procedures, individuals with severe kidney or liver problems, pregnant or breastfeeding participants, those currently participating in another clinical trial, people with a history of drug or alcohol abuse, individuals with certain allergies to the study medication or similar drugs, and those unable to follow study procedures or attend required visits.

Main focus: Participants are randomly assigned to receive either mavacamten capsules or placebo in a double-blind study. The primary outcome is the change in the Valsalva LVOT gradient from the start to Week 28. Secondary outcomes include changes in resting and post-exercise LVOT gradients, heart wall thickness, and other cardiac measurements. Regular monitoring and assessments are conducted throughout the study, which is estimated to conclude by April 2028.

Medication being tested: Mavacamten is administered as oral capsules. It works by inhibiting cardiac myosin, which reduces excessive heart muscle contraction, thereby improving blood flow and potentially reducing the obstruction in the heart’s outflow tract.

Summary

The current landscape of clinical trials for hypertrophic cardiomyopathy reflects significant research activity across Europe, with 13 ongoing studies investigating various therapeutic approaches. A notable concentration of trials is taking place in Western and Central European countries, with Poland, Spain, Italy, France, and Germany hosting the highest number of studies.

The trials predominantly focus on cardiac myosin inhibitors, particularly aficamten and mavacamten, which represent a relatively new class of medications specifically designed for this condition. Several studies are examining these drugs in different patient populations, including adults, adolescents, and children, as well as in both obstructive and non-obstructive forms of the disease. Long-term safety studies are also underway to gather data on extended use of these medications.

Another area of investigation involves SGLT inhibitors, with trials examining sotagliflozin and empagliflozin. These medications were originally developed for other conditions but are now being explored for their potential benefits in managing symptoms and improving heart function.

Traditional cardiovascular medications are also being studied, including beta-blockers and calcium channel blockers, both alone and in comparison with newer treatments. Additionally, one trial is investigating the use of anticoagulants to prevent blood clots in patients with abnormal left atrial function, and another is examining different strategies to manage atrial fibrillation, a common complication.

The diversity of these trials reflects the complexity of the condition and the ongoing effort to develop better treatment options for different patient groups and disease presentations. Patients interested in participating should discuss eligibility criteria and potential benefits with their healthcare providers.

Ongoing Clinical Trials on Hypertrophic cardiomyopathy

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

    Recruiting

    1
    Investigated diseases:
    Austria Belgium France Germany Italy The Netherlands +3

  • Comparing hydrochlorothiazide and valsartan for treating high blood pressure in patients with hypertrophic obstructive cardiomyopathy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study Evaluating Direct Oral Anticoagulants for Prevention of Blood Clots in Patients with Hypertrophic Cardiomyopathy and Abnormal Left Atrial Function

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Sotagliflozin for Improving Symptoms in Patients with Hypertrophic Cardiomyopathy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia France Germany +7

  • Study of Aficamten for Children with Symptomatic Obstructive Hypertrophic Cardiomyopathy

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on the Long-Term Safety of Aficamten (CK-3773274) for Patients with Symptomatic Hypertrophic Cardiomyopathy

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Greece Hungary +6

  • Study on the Effects of Bisoprolol and Verapamil in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Mavacamten for Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Finland France Germany +5

  • Study on Aficamten for Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Hungary Iceland +5

  • Study on the Effects of MYK-224 for Patients with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Spain

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