Hypertrophic Cardiomyopathy (HCM)CAMPHOR-HCMNCT07846176
Aficamten and Patient-Reported Outcomes in Real-World nHCM
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- receiving aficamten
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic non-obstructive hypertrophic cardiomyopathy
Who may be able to join
- 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:
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- 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.
Who cannot join
- LVOTG ≥30 mmHg at rest and/or with provocation.
- LVEF <50% on transthoracic echocardiography.
- Symptomatic hypotension or systolic blood pressure (SBP) <100 mmHg.
- Severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or currently receiving blood purification therapy.
- Planned implantable cardioverter-defibrillator (ICD) implantation or cardiac resynchronization therapy (CRT) within 3 months.
- Women who are pregnant or planning to become pregnant during the trial.
- Currently participating in another investigational device or drug trial.
- Any other clinical condition with an expected survival of less than 2 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comprehensive Aficamten Management and Patient-reported Health Outcomes in Real-world nHCM
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.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- receiving aficamten
- Keywords
- non obstructive hypertrophic cardiomyopathy, aficamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receiving aficamtenDrug
Aficamten will be administered at a specified dose according to each patient's tolerability, as assessed by echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Aficamten group | Patients with non-obstructive hypertrophic cardiomyopathy (nHCM) receiving aficamten therapy Receives: Drug: receiving aficamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (7)
Absolute change from baseline in NT-proBNP
Measured: From enrollment to the end of treatment at 24 months
Percentage change from baseline in TnT/TnI
Measured: From enrollment to the end of treatment at 24 months
Absolute change from baseline in TnT/TnI
Measured: From enrollment to the end of treatment at 24 months
Absolute change from baseline in maximal wall thickness (MWT)
Measured: From enrollment to the end of treatment at 24 months
Absolute change from baseline in E/e'
Measured: From enrollment to the end of treatment at 24 months
Absolute change from baseline in left ventricular end-diastolic volume index (LVEDdi)
Measured: From enrollment to the end of treatment at 24 months
Proportion of patients with improvement of ≥1 NYHA functional class
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846176
- Sponsor's protocol ID
- 2026-1382
- Acronym
- CAMPHOR-HCM
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Aficamten Management and Patient-reported Health Outcomes in Real-world nHCM
- ClinicalTrials.gov ID
- NCT07846176
- Acronym / sponsor ID
- CAMPHOR-HCM / 2026-1382
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- non obstructive hypertrophic cardiomyopathy, aficamten
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aficamten group | – | Drug: receiving aficamtenPatients with non-obstructive hypertrophic cardiomyopathy (nHCM) receiving aficamten therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic non-obstructive hypertrophic cardiomyopathy
Key inclusion criteria (11 listed)
- Age 18-85 years.
- Confirmed diagnosis of HCM:
- Symptomatic nHCM patients meeting all of the following conditions:
- 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.
Key exclusion criteria (8 listed)
- LVOTG ≥30 mmHg at rest and/or with provocation.
- LVEF <50% on transthoracic echocardiography.
- Symptomatic hypotension or systolic blood pressure (SBP) <100 mmHg.
- Severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or currently receiving blood purification therapy.
- Planned implantable cardioverter-defibrillator (ICD) implantation or cardiac resynchronization therapy (CRT) within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| receiving aficamtenAficamten will be administered at a specified dose according to each patient's tolerability, as assessed by echocardiography. | Drug | Aficamten group |
Primary outcome
Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS
Time frame: From enrollment to the end of treatment at 24 months
7 secondary outcomes
Absolute change from baseline in NT-proBNP
Time frame: From enrollment to the end of treatment at 24 months
Percentage change from baseline in TnT/TnI
Time frame: From enrollment to the end of treatment at 24 months
Absolute change from baseline in TnT/TnI
Time frame: From enrollment to the end of treatment at 24 months
Absolute change from baseline in maximal wall thickness (MWT)
Time frame: From enrollment to the end of treatment at 24 months
Absolute change from baseline in E/e'
Time frame: From enrollment to the end of treatment at 24 months
Absolute change from baseline in left ventricular end-diastolic volume index (LVEDdi)
Time frame: From enrollment to the end of treatment at 24 months
Proportion of patients with improvement of ≥1 NYHA functional class
Time frame: From enrollment to the end of treatment at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojie Xie, MD, PhD (86+571-87784700, xiexj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.