NCT07846176Not yet recruiting
Aficamten and Patient-Reported Outcomes in Real-World nHCM
Comprehensive Aficamten Management and Patient-reported Health Outcomes in Real-world nHCM
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively observing changes in symptoms, biomarkers, imaging findings, and adverse reactions, etc. It will also record the dosing regimens at which individual patients achieve steady state, and explore the treatment patterns of Aficamten in Chinese patients with symptomatic nHCM.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 1 Jun 2027
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07846176
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Jun 2027 to the primary completion date, 1 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in another investigational device or drug trial.
Other illness
- Planned implantable cardioverter-defibrillator (ICD) implantation or cardiac resynchronization therapy (CRT) within 3 months.
- Any other clinical condition with an expected survival of less than 2 years.
Lab values
- LVEF \<50% on transthoracic echocardiography.
- Severe renal impairment, estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m², or currently receiving blood purification therapy.
Other
- LVOTG ≥30 mmHg at rest and/or with provocation.
- Symptomatic hypotension or systolic blood pressure (SBP) \<100 mmHg.
- Women who are pregnant or planning to become pregnant during the trial.
Who the study is looking for
- Age 18-85 years.
- Confirmed diagnosis of HCM:
- Left ventricular wall thickness ≥15 mm at any site on echocardiography or cardiac magnetic resonance.
- Left ventricular wall thickness ≥13 mm in individuals testing positive for a pathogenic variant or in genetically affected family members.
- Ventricular wall thickening caused by other cardiovascular diseases or systemic or metabolic disorders has been excluded.
- Symptomatic nHCM patients meeting all of the following conditions:
- Left ventricular outflow tract gradient (LVOTG) \<30 mmHg at rest and/or with provocation.
- Presence of any one of the following symptoms: fatigue (weakness), dyspnea, chest pain, palpitations, or syncope.
- New York Heart Association (NYHA) functional class II or III.
- Left ventricular ejection fraction (LVEF) ≥60% as assessed by transthoracic echocardiography.
- Signed and dated written informed consent, and willingness to return for clinical follow-up.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.