Study on Mavacamten for Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

3 1

What is this study about?

This clinical trial is focused on studying a heart condition called Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). This condition involves the thickening of the heart muscle, which can make it harder for the heart to pump blood. The study will use a treatment called Mavacamten, which is taken as a capsule. Mavacamten is being tested to see if it can help reduce the thickness of the heart wall and the size of the upper heart chamber, known as the atria. The study will use a special imaging technique called Cardiac Magnetic Resonance (CMR) to look at changes in the heart’s structure.

The purpose of this study is to determine if Mavacamten can effectively reduce the thickness of the heart wall and the size of the atria in patients with oHCM. Participants in the study will be randomly assigned to receive either Mavacamten or a placebo, which is a capsule that looks like the medication but does not contain the active ingredient. The study will last for a period of 96 weeks, during which participants will have regular check-ups and imaging tests to monitor their heart condition.

Throughout the study, the impact of Mavacamten on heart function will be assessed, including any improvements in symptoms related to heart failure. The study will also monitor for any other heart-related events to ensure the safety of the treatment. The goal is to see if Mavacamten can provide a beneficial effect on the heart’s structure and function in people with oHCM.

1 joining the study

Upon joining the study, eligibility is confirmed for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), classified as New York Heart Association (NYHA) Functional Class II or III.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes imaging studies using cardiac magnetic resonance (CMR) to evaluate heart wall thickness and the size of the upper heart chamber (atria).

3 medication administration

Participants receive either mavacamten or a placebo. Mavacamten is administered in capsule form, taken orally. The dosage and frequency are determined by the study protocol.

4 ongoing monitoring

Throughout the study, regular monitoring is conducted to assess the impact of the treatment. This includes evaluating changes in heart wall thickness and upper chamber size using CMR at specified intervals.

5 evaluation of heart failure class

The study also evaluates the improvement in heart failure class for participants with symptomatic oHCM, as well as monitoring for any other cardiac events as part of a safety assessment.

6 final assessment

At week 48, a final assessment is conducted to evaluate the efficacy of mavacamten on reducing heart wall thickness and upper chamber size, as well as any improvements in heart failure class.

Who Can Join the Study?

  • Adults with symptomatic obstructive hypertrophic cardiomyopathy can participate. This is a condition where the heart muscle becomes thick, making it harder for the heart to pump blood.
  • Participants should be in NYHA Functional Class II or III. This means they have some limitations in physical activity due to their heart condition, but they are comfortable at rest.
  • Both men and women are eligible to join the study.
  • The study is open to individuals who are considered part of a vulnerable population. This term refers to groups who may need special protection or care.

Who Cannot Join the Study?

  • Patients who have other serious heart conditions besides the one being studied.
  • Patients who have had a heart attack in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who have a pacemaker or other implanted heart device.
  • Patients who have had heart surgery in the past 3 months.
  • Patients with certain types of irregular heartbeats.
  • Patients who are unable to undergo imaging studies, like MRI, due to medical reasons.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Fondazione Toscana Gabriele Monasterio Pisa Italy
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
University General Hospital Of Heraklion Heraklion Greece
Gottsegen National Cardiovascular Center Budapest Hungary
A.O. Krankenhaus St. Josef Braunau GmbH Braunau Am Inn Austria
Onassis Cardiac Surgery Center Kallithea Greece
Nemocnice AGEL Trinec-Podlesi a.s. Konska Czechia
Kardio Brynow Sp. z o.o. Katowice Poland
Hippokration Hospital Athens Greece
Slaskie Centrum Chorob Serca W Zabrzu Zabrze Poland
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Hospital Son Llatzer Palma Spain
Klinik Favoriten Vienna Austria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda USL Toscana Sud Est Arezzo Italy
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
University Of Szeged Szeged Hungary
Hospital Universitario Virgen De La Victoria Malaga Spain
Cdzyjiiqb Ucwvesxxuznrgj Sgmkybqmk Woluwe-Saint-Lambert Belgium
Afaz Dk Skbpz Dz Sjmxfauxx Salamanca Spain
Hxrmzeby Ubxstsrlre Cnqauet Hqgatavq Helsinki Finland
Prvuvdddg Ijlwqgua Mybhpmyy Muwllbgxdwqk Sjepd Wzdemcqnjhvq I Ajepsfzgbrylj Warsaw Poland
Bgjnzgvyrbmzyz Ayuzwm Snscmiowqu Balatonfured Hungary
Hdosqulk Vhgj dqtbtwrg Barcelona Spain
Uaoccbkgrx Gjtmmsh Hreenawg Awdwwfj Athens Greece
Ixlph Ovudtbra Aljstreabd Sgb Lcxv Milan Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
20.11.2023
Belgium Belgium
Not recruiting
20.11.2023
Czechia Czechia
Not recruiting
20.11.2023
Finland Finland
Not recruiting
20.11.2023
France France
Not recruiting
20.11.2023
Germany Germany
Not recruiting
20.11.2023
Greece Greece
Not recruiting
20.11.2023
Hungary Hungary
Not recruiting
20.11.2023
Italy Italy
Not recruiting
20.11.2023
Poland Poland
Not yet recruiting
20.11.2023
Spain Spain
Not recruiting
20.11.2023

Trial locations

Investigated drugs:

Mavacamten is a medication being studied to see if it can reduce the thickness of the heart wall and the size of the upper heart chamber in adults with symptomatic obstructive hypertrophic cardiomyopathy. This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood. The study uses cardiac magnetic resonance imaging (CMR) to assess changes in the heart’s structure while using this medication.

Investigated diseases:

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 from the left ventricle to the aorta. Symptoms may include chest pain, shortness of breath, and palpitations, especially during physical activity. Over time, the heart’s ability to pump blood effectively can be compromised, leading to symptoms of heart failure. The condition can also cause irregular heartbeats, which may be felt as fluttering or pounding in the chest. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe challenges.

Trial ID:
2022-502316-36-00
Protocol code:
CV0271088
Trial Phase:
Human Pharmacology (Phase I) – Other

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