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

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called Mavacamten in adults with a heart condition known as Hypertrophic Cardiomyopathy (HCM). HCM is a disease where the heart muscle becomes abnormally thick, which can make it harder for the heart to pump blood. The study involves participants who have already completed previous trials named MAVERICK-HCM and EXPLORER-HCM. These trials were designed to explore the effects of Mavacamten on different types of HCM, specifically non-obstructive and obstructive forms.

The purpose of this study is to assess how well participants tolerate Mavacamten over a longer period. Participants will take Mavacamten in capsule form, with doses ranging from 2.5 mg to 15 mg. The study will monitor the participants for any major heart-related events, such as heart attacks or strokes, as well as hospitalizations and other heart conditions like heart failure or irregular heartbeats. The study will also look at changes in the heart’s structure and function using imaging techniques like cardiac magnetic resonance imaging (MRI).

Throughout the study, participants will be regularly checked for any side effects or changes in their heart condition. The study aims to provide valuable information on the long-term use of Mavacamten for managing Hypertrophic Cardiomyopathy, helping to understand its safety and effects on heart health over time.

1 initial visit

Upon joining the study, the initial visit involves a comprehensive health assessment. This includes a review of medical history and a physical examination to ensure eligibility.

Participants must have completed a previous study related to hypertrophic cardiomyopathy within 90 days prior to this visit.

2 medication administration

Participants will receive mavacamten in the form of a capsule. The medication is taken orally.

The dosage and frequency of administration will be determined by the study protocol and adjusted as necessary based on individual response and tolerability.

3 regular follow-up visits

Regular follow-up visits are scheduled to monitor health status and the effects of the medication. These visits include physical examinations and laboratory tests.

Participants will undergo echocardiography to assess heart function and structure.

4 cardiac magnetic resonance imaging (CMR)

Participants may undergo CMR to evaluate changes in cardiac mass and structure over time.

This imaging is part of a sub-study for those who meet specific criteria.

5 safety and tolerability assessment

Throughout the study, the safety and tolerability of mavacamten are assessed. This includes monitoring for any adverse events or changes in health status.

Participants are observed for any major cardiac events or hospitalizations.

6 end of study visit

At the conclusion of the study, a final visit is conducted to evaluate overall health and the long-term effects of the medication.

Participants will undergo a final set of assessments, including echocardiography and laboratory tests.

Who Can Join the Study?

  • The patient must have completed the previous study within 90 days of signing consent. If more than 90 days have passed, special approval may be needed. Patients who left the previous study early might still be considered.
  • The patient must understand and follow the study procedures, be aware of the risks, and give informed consent before starting the study.
  • The patient must weigh more than 45 kg (about 99 pounds) at the start of the study.
  • The patient must have good enough heart imaging results to allow accurate tests.
  • The patient must have a left ventricular ejection fraction (LVEF) of 50% or higher. LVEF is a measure of how well the heart pumps blood.
  • The patient’s lab test results must be within normal limits. If not, they can still participate if the results are not considered important by the doctor, liver enzyme levels are less than 3 times the normal limit, and kidney function is adequate.
  • Female patients must not be pregnant or breastfeeding. If sexually active, they must use effective birth control methods during the study and for 4 months after the last dose. These methods include hormonal contraception, an intrauterine device (IUD), or surgical sterilization. Male partners must also use contraception.
  • For the sub-study, the patient must meet specific criteria and be enrolled in the MYK-461-007 Study. Patients from the MAVERICK-HCM Study can join the sub-study, while those from the EXPLORER-HCM Study must have already participated in it.

Who Cannot Join the Study?

  • Participants who have not been previously enrolled in one of the two specific placebo-controlled trials: MAVERICK-HCM for non-obstructive hypertrophic cardiomyopathy or EXPLORER-HCM for obstructive hypertrophic cardiomyopathy.
  • Participants who do not have a diagnosis of hypertrophic cardiomyopathy, which is a condition where the heart muscle becomes thickened.
  • Participants who are not within the specified age range for the study.
  • Participants who are not part of the specified clinical trial groups.
  • Participants who are not considered part of the vulnerable population selected 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 Status
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Azienda Ospedaliero Universitaria Careggi Florence Italy
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Toulouse Toulouse France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Assistance Publique Hopitaux De Paris Paris France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Frederiksberg Hospital Frederiksberg Denmark
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH Dresden Germany
Kardio Brynow Sp. z o.o. Katowice Poland
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Odense University Hospital Odense Denmark
Alunferaqg Pxuqzfyv Htbvjqfu Di Paljt Paris France
Eeektye Uwrdfzddjzjp Mlwtlec Cgqtcos Rvpzclery (nyafyuu Mch Rotterdam The Netherlands
Abgtzs Ubvaovqcxn Hnqqdzrb Aarhus Denmark
Uqvnvfxggq Ou Awzdkvx Edegem Belgium
Ihfmyaibp Fdl Czirgzch Ame Evqnqeronpif Mmwifytb Prague Czechia
Ohpqbzcccaqhyojuoooigkridu Aalst Belgium
Heppbshs Uxezeahdkmfkb dy A Cvfiua 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
Belgium Belgium
Not recruiting
10.05.2018
Czechia Czechia
Not recruiting
10.05.2018
Denmark Denmark
Not recruiting
10.05.2018
France France
Not recruiting
10.05.2018
Germany Germany
Not recruiting
10.05.2018
Italy Italy
Not recruiting
10.05.2018
Poland Poland
Not recruiting
10.05.2018
Portugal Portugal
Not recruiting
10.05.2018
Spain Spain
Not recruiting
10.05.2018
The Netherlands The Netherlands
Not recruiting
10.05.2018

Trial locations

Investigated drugs:

Mavacamten (MYK-461) is a medication being studied for its long-term safety and effects in adults with hypertrophic cardiomyopathy (HCM). This condition causes the heart muscle to thicken, which can make it harder for the heart to pump blood. Mavacamten is designed to help the heart muscle relax, potentially improving heart function and symptoms in people with HCM. The study aims to understand how safe and tolerable mavacamten is over a long period and how it affects the heart’s size and structure.

Investigated diseases:

Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. The thickening can occur in different parts of the heart, but it most commonly affects the septum, the wall that separates the left and right sides of the heart. As the heart muscle thickens, it can lead to problems with the heart’s electrical system, potentially causing irregular heartbeats. Over time, the thickened heart muscle can also lead to stiffness, reducing the heart’s ability to fill with blood between beats. This condition can be obstructive, where the thickened muscle blocks blood flow out of the heart, or non-obstructive, where there is no blockage. Symptoms can vary widely, with some individuals experiencing shortness of breath, chest pain, or fainting, while others may have no symptoms at all.

Trial ID:
2022-502858-14-00
Protocol code:
MYK 461-007
NCT ID:
NCT03723655
Trial Phase:
Therapeutic confirmatory (Phase III)

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