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Study on Mavacamten for Adults with Non-obstructive Hypertrophic Cardiomyopathy

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What is this study about?

This clinical trial is focused on studying a heart condition called Non-obstructive Hypertrophic Cardiomyopathy. This condition involves the thickening of the heart muscle, which can make it harder for the heart to pump blood. The study will evaluate a treatment called Mavacamten, which is taken as a capsule. Mavacamten is being tested to see if it can help improve symptoms and physical limitations in people with this heart condition.

The purpose of the study is to compare the effects of Mavacamten with a placebo over a period of 48 weeks. Participants will be randomly assigned to receive either Mavacamten or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will monitor changes in health status, including symptoms and exercise capacity, to determine the effectiveness of Mavacamten.

Throughout the study, participants will take the medication orally and will have regular check-ups to assess their condition. The study aims to provide valuable information on whether Mavacamten can be a beneficial treatment for individuals with Non-obstructive Hypertrophic Cardiomyopathy, potentially improving their quality of life by reducing symptoms and enhancing their ability to perform physical activities.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the active medication, mavacamten, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

2 medication administration

The participant will take the assigned medication orally in the form of a capsule. The dosage and frequency will be determined by the study protocol, and the treatment will last for a duration of 48 weeks.

3 monitoring and assessments

Throughout the 48-week period, the participant’s health status, symptoms, and physical limitations will be regularly assessed. This includes monitoring exercise capacity and other health indicators.

4 primary outcome evaluation

The primary outcomes will be evaluated by measuring changes from the baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) and peak oxygen consumption (pVO2) at week 48.

5 secondary outcome evaluation

Secondary outcomes will include changes in the VE/VCO2 slope, improvement in New York Heart Association (NYHA) class, and changes in biomarkers such as NT-pro BNP and cTn-T. Additionally, the time to first major adverse cardiovascular events (MACE-Plus) will be recorded.

6 completion of the study

At the end of the 48-week period, the participant will complete the study. Final assessments will be conducted to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • Participants must be at least 18 years old or the local age of majority.
  • Female participants must use highly effective birth control methods or have proof that they cannot have children.
  • Male participants do not need to use additional birth control measures.
  • Participants must have a diagnosis of Hypertrophic Cardiomyopathy (HCM), which is a condition where the heart muscle becomes thickened, following specific medical guidelines.
  • The peak LVOT pressure gradient must be less than 30 mmHg at rest and less than 50 mmHg during certain tests. This measures the pressure difference in the heart.
  • Participants must have an oxygen level at rest greater than 90% during screening and be able to perform a special exercise test called cardiopulmonary stress test (CPET). This test checks how well the heart and lungs work during physical activity.
  • Participants must be in New York Heart Association (NYHA) Class II or III, which describes the severity of heart failure symptoms.
  • Participants must have a NT-proBNP level of 200 pg/mL or higher, or a BNP level of 70 pg/mL or higher. These are blood tests that help measure heart function.
  • The LVEF (Left Ventricular Ejection Fraction) must be 60% or higher on an echocardiogram, which is an ultrasound of the heart.
  • The KCCQ-23 CSS Score must be 85 or lower at screening. This score measures the impact of heart failure on a person’s life.

Who Cannot Join the Study?

  • Patients with other types of heart conditions that are not related to Non-obstructive Hypertrophic Cardiomyopathy cannot participate. This is a condition where the heart muscle becomes thickened without blocking blood flow.
  • Individuals who are not within the specified age range for the study are excluded. The study is designed for certain age groups only.
  • Participants who are unable to follow the study procedures or take the study medication as required will not be eligible.
  • People with certain medical conditions or who are taking medications that might interfere with the study treatment are not allowed to join.
  • Pregnant or breastfeeding women are not eligible to participate in the study.
  • Individuals who have participated in another clinical trial recently may be excluded to avoid interference with the study results.
  • Patients with a history of drug or alcohol abuse that could affect their ability to follow the study requirements are not eligible.
  • Anyone who has a known allergy or adverse reaction to the study medication or similar drugs cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
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
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
St. Olavs Hospital HF Trondheim Norway
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Hospital Universitario Virgen De Las Nieves Granada Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
A.O. Krankenhaus St. Josef Braunau GmbH Braunau Am Inn Austria
Klinikum Bielefeld gGmbH Bielefeld Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Kardio Brynow Sp. z o.o. Katowice Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen Munich Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Da Luz S.A. Lisbon Portugal
Semmelweis University Budapest Hungary
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Son Llatzer Palma Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Edumed s.r.o. Nachod Czechia
University Of Szeged Szeged Hungary
Hospital Universitario Virgen De La Victoria Malaga Spain
Owcaqbxlrbabnq Lnqs Gjfd Linz Austria
Ibtjmvpch Fhd Cyexvkmj Azm Escjtfcqmcci Mnniueft Prague Czechia
Uyhislsanz Htkhrtka Clpiljg Cologne Germany
Abflxyczc Uhn Amsterdam The Netherlands
Aaxdbqfu Upajpheshc Hihamkah Lorenskog Norway
Smvdegjfm Rgydpzl Upubejtauq Mijoths Ckqpyy Nijmegen The Netherlands
Emleudj Uhdhkrojbjft Mqkwuic Cjqpvzg Rfeehjfsr (nocbanu Mpx Rotterdam The Netherlands
Atwtfi Uxmsfjbanq Hsfiqnts Aarhus Denmark
Cghypj Hwpbraiqntv Rdepxhvf Uvfpshwhefnno Dp Tbgld Tours France
Ubwmnprgelucddczndefi Mrkpnpxr Ahk Munster Germany
Peqdsemha Iedwadrc Mqdirymr Mutecmaufuha Suthj Wyvmqwkcvzks I Afczgpfbccrlj Warsaw Poland
Kojvbiwq dcr Ucjylcuifwxi Mefwxleh Aif Munich Germany
Bhvmcrsdynennc Amlewu Spqpertihp Balatonfured Hungary
Umjprezate Og Avfidgo Edegem Belgium
Htroxogk Vsfm ddqwmmxx Barcelona Spain
Haygqazy Ujgjhnjnouphv dk A Cqkpeh A Coruna Galicia Spain

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
12.04.2023
Belgium Belgium
Not recruiting
12.04.2023
Czechia Czechia
Not recruiting
12.04.2023
Denmark Denmark
Not recruiting
12.04.2023
France France
Not recruiting
12.04.2023
Germany Germany
Not recruiting
12.04.2023
Hungary Hungary
Not recruiting
12.04.2023
Italy Italy
Not recruiting
12.04.2023
Norway Norway
Not recruiting
12.04.2023
Poland Poland
Not recruiting
12.04.2023
Portugal Portugal
Not recruiting
12.04.2023
Spain Spain
Not recruiting
12.04.2023
The Netherlands The Netherlands
Not recruiting
12.04.2023

Trial locations

Investigated drugs:

Mavacamten is a medication being studied for its potential to help adults with symptomatic nonobstructive hypertrophic cardiomyopathy. This condition involves the thickening of the heart muscle, which can lead to symptoms like shortness of breath and reduced exercise capacity. Mavacamten works by targeting the heart muscle to improve its function, potentially reducing symptoms and improving the ability to exercise. The clinical trial aims to evaluate how effective a 48-week course of mavacamten is in improving patients’ health status and physical limitations compared to not receiving the medication.

Investigated diseases:

Non-obstructive Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick without blocking blood flow. The thickened heart muscle can make it harder for the heart to pump blood efficiently. Over time, this can lead to symptoms such as shortness of breath, chest pain, and palpitations. The disease may progress slowly, and symptoms can vary widely among individuals. Some people may experience significant physical limitations, while others may have mild or no symptoms. The condition is often inherited and can be detected through family history.

Trial ID:
2023-506352-24-00
Protocol code:
CV027-031
NCT ID:
NCT05582395
Trial Phase:
Therapeutic confirmatory (Phase III)

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