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A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Study acronym: CAMELLIA-HCM
StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Completion moved earlier from May 30, 2028 to Apr 28, 2028 Study sites: 25 to 24v16 Show 1 more changeShow less
    • Study sites: 25 to 24
  2. Minor 4 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv12-v15
  3. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 34 to confirmed 36 · Site details revised at 25 of 25 sitesv11 Show 2 more changesShow less
    • Enrollment target: estimated 34 to confirmed 36
    • Site details revised at 25 of 25 sites
  4. Minor Re-verified, no change to tracked fieldsv10
  5. Minor Site details revised at 1 of 25 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Site details revised at 8 of 25 sitesv8
  2. Minor Site details revised at 1 of 25 sitesv7
  3. Minor Site details revised at 7 of 25 sitesv6
  4. Minor Site details revised at 5 of 25 sitesv5
  5. Minor Completion date: Apr 28, 2028 to May 30, 2028v4
  6. Minor Study sites: 24 to 25 Secondary endpoints: details revised at 1 of 9 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 9 entries
  7. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 20, 2025 to Jun 30, 2025 · Secondary endpoints: details revised at 1 of 9 entries · Site details revised at 24 of 24 sitesv2 Show 3 more changesShow less
    • Start date changed from estimate of Jun 20, 2025 to Jun 30, 2025
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised at 24 of 24 sites
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
131 trials monitored
See 7 trials at risk
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM). Obstructive hypertrophic cardiomyopathy (oHCM) is a type of heart disease where the heart muscles become thicker than normal due to over contraction. This thickening makes it harder than normal due to over contraction. This thickening makes it harder for the heart to pump blood out to the rest of the body. In symptomatic oHCM people with the condition experience symptoms like shortness of breath, chest pain, fainting, high blood pressure and irregular heartbeats. The study treatment aficamten, also called BAY3723113, is under development to treat symptomatic oHCM. It aims to reduce the activity of cardiac myosin, a protein that helps heart muscles to contract, and thereby preventing over contraction and muscle thickening. Although treatment options are available for symptomatic oHCM, there is still need for other treatment options that help target the root cause of the condition. In this study, researchers want to understand about the effects and long-term safety of aficamten in Japanese people with symptomatic oHCM. The main purpose of the study is to learn how well aficamten works in Japanese with symptomatic oCHM. For this, the researchers will check how participant's heart blood flow changes after 6 months of treatment. They do this by measuring the pressure needed for blood to leave the heart using a test called the left ventricular outflow tract (LVOT) gradient and a special breathing technique called Valsava maneuver. Researchers will also look for: * the number of participants who will have at least 1 level improvement on a scale doctors use to assess the effect of heart problems on daily activities after 3 and 6 months of treatment * the change in the impact of heart problems on participant's daily lives based on their feedback on a questionnaire called Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 3 and 6 months of treatment. This study will have 2 treatment periods: main treatment period and long-term treatment period. During the main treatment period, participants will take aficamten tablets once daily by mouth for up to 6 months. After completing this period, the participants who can join the long-term treatment period will continue taking aficamten until the drug becomes commercially available in Japan or the study ends. Each participant will be in the study as long as they benefit from the treatment. Participants will visit the study site: * once before the treatment starts * 9 times with a gap of 2 to 4 weeks between the visits during treatment under the main treatment period, and in the long-term treatment period, participants will visit almost every 3 months until the treatment ends. * then 2 more times with a gap of 1 month between the visits after the treatment ends. During the study, the study doctors and their team will: * check participant's health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) and echocardiogram (ECHO) * ask the participants questions about how they are feeling and what adverse events are they having An adverse event is any medical problem that a participant has during a study. Study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. If the participant benefits from the treatment, treatment with aficamten after the end of the study might be possible.
Trial Details
NCT Number NCT07023341
Lead Sponsor Bayer
Conditions Obstructive Hypertrophic Cardiomyopathy
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov