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

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Aficamten (also known by its code name CK-3773274) in patients 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 purpose of this study is to gather information on the long-term safety and how well patients tolerate Aficamten when used to treat symptoms of HCM.

Participants in the study will take Aficamten in the form of a film-coated tablet, which is taken orally. The study will monitor patients over a period to observe any side effects or changes in their condition. The study aims to ensure that Aficamten is safe for long-term use and to understand how it affects the heart’s function in people with HCM. The study will also compare the effects of Aficamten with a placebo to determine its effectiveness.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur during the trial. They will also monitor the heart’s performance, specifically looking at the heart’s ability to pump blood effectively. This will help determine if Aficamten can be a safe and effective treatment option for people living with symptomatic HCM. The study is designed to provide valuable insights into the management of this heart condition and improve treatment options for patients in the future.

1 joining the study

Upon joining the study, the patient will begin treatment with aficamten, a medication used to manage symptoms of hypertrophic cardiomyopathy (HCM).

The medication is administered in the form of a film-coated tablet and is taken orally.

2 medication administration

The patient will take aficamten as prescribed by the study protocol. The specific dosage and frequency will be determined by the study team based on individual needs and responses.

The treatment is designed to be long-term, with regular monitoring to assess safety and tolerability.

3 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor the effects of the medication. This includes checking for any adverse events and measuring heart function.

Key assessments include monitoring the left ventricular ejection fraction (LVEF) and left ventricular outflow tract gradient (LVOT-G) at rest and during specific maneuvers.

4 follow-up evaluations

The patient will have follow-up evaluations at 12-week intervals to assess changes from baseline measurements.

These evaluations will help determine the effectiveness of the treatment and any necessary adjustments to the medication regimen.

5 completion of study participation

The study is expected to continue until June 2026, with the patient participating for the duration specified in the study protocol.

Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • The patient must understand and be willing to sign a consent form and follow all study procedures and rules for the entire study period.
  • The patient should have completed a previous study involving the drug CK-3773274. If they couldn’t complete it due to reasons not related to following rules or safety, a medical expert will decide if they can join.
  • The patient must have a left ventricular ejection fraction (LVEF) of 55% or higher. This is a measure of how well the heart pumps blood.
  • Male patients must agree to not donate sperm during the study and for at least 10 weeks after the last dose of the study drug. They must also either not have heterosexual intercourse or use a condom and ensure their female partner uses a highly effective birth control method during the study and for 4 weeks after the last dose.
  • Female patients must not be pregnant, breastfeeding, or planning to donate eggs. They must either not be able to become pregnant or, if they can become pregnant, use a highly effective birth control method and have their male partner use a condom during the study and for 4 weeks after the last dose. They must also have a negative pregnancy test before starting the study drug.
  • The patient must be willing and able to complete all initial screening tests.

Who Cannot Join the Study?

  • Patients who have other serious heart conditions besides hypertrophic cardiomyopathy (HCM), which is a condition where the heart muscle becomes thickened.
  • Patients who have had a heart attack or heart surgery in the past three months.
  • Patients with uncontrolled high blood pressure, meaning their blood pressure is not well-managed with medication or lifestyle changes.
  • Patients with severe liver or kidney disease, which means their liver or kidneys are not working properly.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for the baby.
  • Patients who are participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of drug or alcohol abuse, which means they have used drugs or alcohol in a way that is harmful to their health.
  • Patients who have a known allergy to the study medication or any of its ingredients.

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
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Fondazione Toscana Gabriele Monasterio Pisa Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Hospital Cuf Descobertas S.A. Lisbon Portugal
Onassis Cardiac Surgery Center Kallithea Greece
Kardio Brynow Sp. z o.o. Katowice Poland
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
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
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Son Llatzer Palma Spain
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Hopital Beaujon Clichy France
Roskilde University Roskilde Denmark
University Of Szeged Szeged Hungary
Hospital Universitario Virgen De La Victoria Malaga Spain
Uqkmqnrchegoifwixtmck Evtca Amx Essen Germany
Ctxuhimw Hmxwrpeucwft Ujhtlcxoqszxf Ds Vbyb Vigo Spain
Aonrjfnfyr Prbygvag Hhmrzkco Df Mnsslhkjr Marseille France
Epcbxic Ujhjxpnlzczr Mkckhfb Czlnpmj Rgztalltn (qjzncpu Mwa Rotterdam The Netherlands
Atwoir Uluofjzdrx Hadhywdy Aarhus Denmark
Aawjikell Umz Amsterdam The Netherlands
Cbmcctow Dx Mczxesbwmw Montpellier France
Utiujvxujfmauwdthhnui Wnizxaypj Awf Wuerzburg Germany
Hsshqnad Dl Lk Slojw Ckob I Sqwa Pxz Barcelona Spain
Hczcqskf Ulqqmkalomsud dv A Cqleam A Coruna Galicia Spain
Unnwflmeww Gxzvdvo Hkagvpas Aznybkf Athens Greece

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
04.06.2021
Denmark Denmark
Recruiting
04.06.2021
France France
Recruiting
04.06.2021
Germany Germany
Recruiting
04.06.2021
Greece Greece
Recruiting
04.06.2021
Hungary Hungary
Recruiting
04.06.2021
Iceland Iceland
Recruiting
04.06.2021
Italy Italy
Recruiting
04.06.2021
Poland Poland
Recruiting
04.06.2021
Portugal Portugal
Recruiting
04.06.2021
Spain Spain
Recruiting
04.06.2021
The Netherlands The Netherlands
Recruiting
04.06.2021

Trial locations

Investigated drugs:

Aficamten (CK-3773274) is a medication being studied for its effects on patients with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle becomes abnormally thick. This medication is being evaluated to see if it is safe and well-tolerated by patients who have symptoms of HCM. The goal is to understand how this treatment can help manage the condition over a sustained period.

Investigated diseases:

Hypertrophic Cardiomyopathy – Hypertrophic cardiomyopathy (HCM) is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. This 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. Symptoms may include chest pain, shortness of breath, and fainting, especially during physical activity. The progression of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing more significant challenges.

Trial ID:
2023-508963-58-00
Protocol code:
CY 6022
NCT ID:
NCT04848506
Trial Phase:
Therapeutic exploratory (Phase II)

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