A Study of Danicamtiv for Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy to Test if it Improves Heart Function and Exercise Ability

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What is this study about?

This study is looking at a condition called dilated cardiomyopathy, which is a disease where the heart muscle becomes weakened and stretched, making it harder for the heart to pump blood effectively. This particular study focuses on people who have this condition because of changes in their genes that they were born with or that run in their family. The treatment being tested is called danicamtiv, which is also known by the code names BMS-986434 and MYK-491. Some people in the study will receive danicamtiv tablets while others will receive placebo tablets.

The purpose of this study is to find out if danicamtiv can help improve heart function and exercise ability in people with this genetic form of heart muscle disease. The study is divided into two parts. In the first part, the researchers will use a heart imaging test called transthoracic echocardiogram, which is an ultrasound of the heart, to see if the medication affects how well the heart works. In the second part, they will use cardiopulmonary exercise testing, which measures how much oxygen the body uses during exercise, to see if the medication helps people exercise better. The study will measure these changes over a period of 26 weeks.

During the study, participants will take either danicamtiv or placebo tablets by mouth for up to 26 weeks. The study uses a method where neither the participants nor the doctors know who is receiving the actual medication and who is receiving the placebo. Participants will need to attend regular visits where they will have heart ultrasounds and exercise tests to check how their heart is functioning and how well they can exercise. The study is looking at people who are at least 18 years old and have symptoms of this genetic heart condition with an enlarged left side of the heart.

1 Initial assessment and baseline measurements

At the start of the study, your heart function will be assessed using a transthoracic echocardiogram. This is an ultrasound test that creates images of your heart to see how well it is working.

Your exercise capacity will be measured through cardiopulmonary exercise testing. During this test, you will perform exercise on a stationary bike or treadmill while your oxygen consumption and heart function are monitored.

These initial measurements will serve as your baseline, which means they will be used to compare against later results during the study.

2 Treatment assignment

You will be randomly assigned to receive either danicamtiv tablets or placebo tablets. The placebo tablets look identical to the danicamtiv tablets but do not contain the active substance.

Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study and helps ensure accurate results.

All tablets will be taken by mouth.

3 Treatment period

You will take your assigned tablets as directed throughout the treatment period.

The study is divided into two parts. Part 1 focuses on assessing heart function, and Part 2 evaluates exercise capacity.

You will continue taking the medication according to the schedule provided by the study team.

4 Week 26 assessment

At week 26, you will undergo the same tests that were performed at the beginning of the study.

A transthoracic echocardiogram will be performed to measure changes in your left atrial function index. The left atrium is one of the chambers of your heart, and this measurement helps determine how well it is functioning.

Your exercise capacity will be tested again using cardiopulmonary exercise testing to measure your peak oxygen consumption. This shows the maximum amount of oxygen your body can use during intense exercise.

These results will be compared to your baseline measurements to determine the effect of the treatment.

5 Follow-up period

After completing the treatment period, you will enter a follow-up phase.

If you are sexually active, you must continue using one of the highly effective birth control methods for 3 months after taking your last dose of the study medication.

Additional assessments may be conducted during this period as specified by the study protocol.

Who Can Join the Study?

You must be 18 years of age or older at the time of the screening visit
You must have a diagnosis of dilated cardiomyopathy, which is a condition where the heart becomes enlarged and weakened, caused by specific genetic changes in genes such as MYH7, TTN, or other identified genetic variants, or have a family history of this heart condition
You must have New York Heart Association Class II to IV symptoms, which is a way doctors classify how much your heart condition limits your physical activity, ranging from slight limitation to severe limitation, and these symptoms must be stable for at least 1 month
You must have at least mild left ventricular enlargement, which means the main pumping chamber of your heart is larger than normal, confirmed by specific measurements on an ultrasound of the heart, and the ultrasound images must be clear enough for accurate assessment
You must have chronic dilated cardiomyopathy, meaning your heart condition is long-lasting and not caused by temporary or reversible conditions such as thyroid problems, infections, irregular fast heartbeats, or iron buildup
Your heart condition must not be caused by substance abuse, amyloidosis (a condition where abnormal proteins build up in organs), sarcoidosis (an inflammatory disease), or any other secondary form of heart muscle disease
You must have a normal heart rhythm, stable pacing from a device, or occasional irregular heartbeat that is well-controlled, to allow proper heart ultrasound assessments
You must be able to perform an upright exercise test that measures how well your heart and lungs work during physical activity, with results showing your peak oxygen consumption is 80% or less of what is expected for a healthy person, and meeting specific breathing measurement requirements
If you are sexually active, you must use highly effective birth control methods from the screening visit until 3 months after your last dose of the study medication
You must be able to understand and follow the study procedures, understand the risks involved, and provide written consent before any study procedures begin

Who Cannot Join the Study?

The study document does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in this clinical trial.
If you are interested in this study, the research team would need to evaluate your individual medical situation to determine if you meet all requirements for participation.
General factors that often prevent participation in heart studies may include other serious medical conditions, certain medications you are taking, recent heart procedures, pregnancy or plans to become pregnant, or inability to perform required tests.
The study involves testing a medication called danicamtiv in patients with a specific heart condition called dilated cardiomyopathy, which is a condition where the heart muscle becomes weakened and enlarged, often passed down in families.
The study will use special heart imaging tests called echocardiograms, which use sound waves to create pictures of your heart, and exercise tests that measure how well your heart and lungs work during physical activity.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium
University Hospital Maastricht	Maastricht	The Netherlands
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Danderyds Sjukhus AB	Danderyd	Sweden
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Son Llatzer	Palma	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Rigshospitalet	Copenhagen	Denmark
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Semmelweis University	Budapest	Hungary
Region Midtjylland	Aarhus	Denmark
Hopital Beaujon	Clichy	France
University Of Szeged	Szeged	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Policlinico Casilino	Rome	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Azorg	Aalst	Belgium
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Soedersjukhuset AB	Stockholm	Sweden
Alqwoqhzi Ucv	Amsterdam	The Netherlands
Uiwuaofeyt Oi Abbehti	Edegem	Belgium
Emoxkxs Uxrngwsediay Mqepiua Cnfmhnp Raycefezm (ynpszhr May	Rotterdam	The Netherlands
Hhashwuu Vwyl dlrldehc	Barcelona	Spain
Hxjnuhny Uxkvnsiklnkce df A Coszme	A Coruna Galicia	Spain
Kpholuysw Sfqllni Szqhlhsmbtaabcd ib Jjhr Ptlfz Id	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.02.2026
Denmark	Recruiting	13.02.2026
France	Recruiting	13.02.2026
Hungary	Recruiting	13.02.2026
Italy	Recruiting	13.02.2026
Poland	Recruiting	13.02.2026
Spain	Recruiting	13.02.2026
Sweden	Recruiting	13.02.2026
The Netherlands	Recruiting	13.02.2026

Trial locations

Investigated drugs:

Danicamtiv

Danicamtiv is an investigational medication being studied for the treatment of dilated cardiomyopathy, a condition where the heart muscle becomes weakened and enlarged, making it difficult for the heart to pump blood effectively. This medication is designed to help improve how the heart muscle contracts and functions. In this study, researchers want to see if danicamtiv can improve heart function and increase the ability of patients to exercise.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of danicamtiv against no active treatment, helping researchers determine if the medication truly works.

Dilated Cardiomyopathy – Dilated cardiomyopathy is a heart muscle disease where the heart’s main pumping chamber becomes enlarged and weakened. The left ventricle stretches and becomes thinner, making it harder for the heart to pump blood effectively throughout the body. As the condition progresses, the heart muscle loses its ability to contract properly, leading to reduced blood flow to organs and tissues. This can result in fluid buildup in the lungs, legs, and other parts of the body. The heart may also develop irregular rhythms as it tries to compensate for its weakened pumping ability. When the disease has a genetic or familial origin, it means it runs in families and is passed down through inherited genes.

Trial ID:

2025-522553-19-00

Protocol code:

DAN-301

Trial Phase:

Therapeutic use (Phase IV)

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A Study of Danicamtiv for Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy to Test if it Improves Heart Function and Exercise Ability

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?