Study Comparing Aficamten and Metoprolol for Adults with Symptomatic Hypertrophic Cardiomyopathy

3 1 1

What is this study about?

This clinical trial is focused on studying a heart condition known as Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). This condition involves the thickening of the heart muscle, which can obstruct blood flow and cause symptoms like shortness of breath, chest pain, and fainting. The study aims to compare the effects of a new medication called Aficamten (also known by its code name CK-3773274) with a commonly used medication called Metoprolol. Aficamten is taken as a film-coated tablet, while Metoprolol is taken as a prolonged-release tablet. The trial also includes a placebo group for comparison.

The purpose of the study is to evaluate how well Aficamten improves exercise capacity in people with oHCM compared to Metoprolol. Participants will be randomly assigned to receive either Aficamten, Metoprolol, or a placebo. The study will last for about 24 weeks, during which participants will take their assigned medication and undergo various assessments to monitor their heart function and overall health. These assessments will include tests to measure how much oxygen the body uses during exercise, as well as questionnaires to evaluate symptoms and quality of life.

Throughout the study, participants will have regular check-ups to ensure their safety and to track any changes in their condition. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps to ensure that the results are unbiased and reliable. The ultimate goal is to determine whether Aficamten can offer a new and effective treatment option for people living with oHCM.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Diagnostic tests such as cardiac magnetic resonance imaging (CMR) or echocardiography are performed to confirm the diagnosis of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

2 baseline measurements

Baseline measurements are taken, including peak oxygen uptake (pVO2) through cardiopulmonary exercise testing (CPET).

Additional assessments include the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS) and echocardiographic measurements.

3 randomization and treatment initiation

Participants are randomly assigned to receive either aficamten or metoprolol succinate. Aficamten is administered as a film-coated tablet, while metoprolol succinate is provided as a prolonged-release tablet.

The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.

4 treatment period

The treatment period lasts for 24 weeks. During this time, participants continue to take their assigned medication.

Regular follow-up visits are scheduled to monitor health status, medication adherence, and any side effects.

5 mid-study assessments

At the midpoint of the study, additional assessments are conducted to evaluate progress. These include repeat CPET, KCCQ-CSS, and echocardiographic measurements.

Adjustments to medication dosage may be made based on these assessments.

6 final assessments

At the end of the 24-week treatment period, final assessments are conducted. These include CPET, KCCQ-CSS, and echocardiographic measurements to evaluate changes from baseline.

The primary endpoint is the change in peak oxygen uptake (pVO2) from baseline to Week 24.

7 study completion

Upon completion of the study, participants may receive information about their treatment group and overall study results.

Participants are encouraged to discuss their ongoing treatment plan with their healthcare provider.

Who Can Join the Study?

Participants must be males or females between the ages of 18 and 85.
Participants should have a body mass index (BMI) of less than 35. BMI is a measure of body fat based on height and weight.
Participants must be diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) using specific heart imaging tests like cardiac magnetic resonance imaging (CMR) or echocardiography. This includes having a thickened heart muscle (LV hypertrophy) without other heart diseases and a certain thickness of the heart wall.
Participants should have a KCCQ score of 90 or less. The KCCQ is a questionnaire that measures heart failure symptoms and their impact on daily life.
Participants need to have a specific heart measurement from an echocardiogram, which includes a resting LVOT-G greater than 30 mm Hg or a post-Valsalva LVOT-G of 50 mm Hg or more. LVOT-G refers to the pressure gradient in the left ventricular outflow tract. Additionally, the left ventricular ejection fraction (LVEF) should be 60% or higher, which measures how well the heart pumps blood.
Participants must have a hemoglobin level of 10 g/dL or higher. Hemoglobin is a protein in red blood cells that carries oxygen.
Participants who have previously taken a medication called mavacamten can join the study, but they must have stopped taking it at least 8 weeks before participating.

Who Cannot Join the Study?

Participants with other serious heart conditions that are not related to Obstructive Hypertrophic Cardiomyopathy (a condition where the heart muscle becomes thickened, making it harder for the heart to pump blood).
Individuals who have had a heart attack or stroke in the past six months.
People with uncontrolled high blood pressure.
Participants with severe liver or kidney disease.
Individuals who are pregnant or breastfeeding.
People who are currently participating in another clinical trial.
Participants with a history of drug or alcohol abuse in the past year.
Individuals with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Bispebjerg Hospital	Copenhagen	Denmark
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Son Llatzer	Palma	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Semmelweis University	Budapest	Hungary
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Enuhhre Ukqmkbqihiyh Mmldgwt Cmzglxo Rufbhpaui (usublke Mto	Rotterdam	The Netherlands
Aktqwdqsqi Pjdomdie Hvzdezmz Df Pifpb	Paris	France
Asfjbjedld Pptxovqa Hdimpwyd De Mnushhucw	Marseille	France
Aqtokp Ureaijeyrw Hpvfclhv	Aarhus	Denmark
Ufqsoqpyvesfhdrvfaemo Ekorw Aun	Essen	Germany
Hkhbirye Utnztkilxfzqo di A Cujrrm	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.10.2023
France	Not recruiting	01.10.2023
Germany	Not recruiting	01.10.2023
Hungary	Not recruiting	01.10.2023
Italy	Not recruiting	01.10.2023
Spain	Not recruiting	01.10.2023
The Netherlands	Not recruiting	01.10.2023

Trial locations

Investigated drugs:

Aficamten is a medication being studied for its potential to improve exercise capacity in people with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood. Aficamten is being tested to see if it can help the heart work more efficiently and improve symptoms like shortness of breath and fatigue during physical activity.

Metoprolol is a medication commonly used to treat high blood pressure and heart-related issues. In this trial, it is being used as a comparison to aficamten to see which medication is more effective in improving exercise capacity in people with symptomatic obstructive hypertrophic cardiomyopathy. Metoprolol works by slowing down the heart rate and reducing the heart’s workload, which can help alleviate symptoms associated with this condition.

Symptomatic Obstructive Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. The thickening often occurs in the septum, the wall dividing the left and right sides of the heart, which can obstruct blood flow out of the heart. Symptoms may include shortness of breath, chest pain, and palpitations, especially during physical activity. Over time, the heart’s ability to pump blood effectively can be compromised, leading to further symptoms and complications. The condition is often diagnosed in adulthood, but symptoms can appear at any age. It is a chronic condition that requires ongoing management to alleviate symptoms and improve quality of life.

Trial ID:

2023-504809-37-00

Protocol code:

CY 6032

NCT ID:

NCT05767346

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study Comparing Aficamten and Metoprolol for Adults with Symptomatic Hypertrophic Cardiomyopathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?