Hypertrophic Cardiomyopathy (HCM)Phase 4CMI-SWITCHNCT07600177
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
A Phase 4 study testing Aficamten in people with Hypertrophic Cardiomyopathy (HCM), run by Oregon Health and Science University at 2 sites in United States.
Trial summary
This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- Aficamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2026to 15 Mar 2027
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history of oHCM with documented resting and/or Valsalva LVOT obstruction ≥ 50 mmHg who are currently receiving mavacamten commercially.
- Echo-derived LVEF ≥55% on mavacamten at the time of enrollment.
- Patient willing to consent for the study and undergo the study procedures.
Who cannot join
- Severe aortic stenosis or sub-aortic obstruction
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LVEF <30%.
- Paroxysmal atrial fibrillation (AF) with documented episode within 3 months.
- Atrial fibrillation (paroxysmal or permanent) not on systemic anticoagulation.
- Documented history of current obstructive coronary artery disease (> 70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
St. Luke's Hospital - Mid America Heart Institute
Kansas City, Missouri, 64111
Michael Nassif, MD, 816-932-3458, mnassif@saint-lukes.org
Michael Nassif, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Ahmad Masri, MD, 503-494-7551, masria@ohsu.edu
About this study
This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- Aficamten
- Keywords
- aficamten, mavacamten, cardiac myosin inhibitor, CMI
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AficamtenDrug
Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| CMI | Experimental | Switching from mavacamten on day 1 to aficamten starting at week 2. Receives: Drug: Aficamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints
To describe the safety of this proposed protocol. These include:
- Participant incidence of reported AEs
- Participant incidence of reported SAEs
- Participant incidence of LVEF < 40%
Measured: Up to 16 weeks
Secondary outcomes (4)
Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment
Measured: Up to 16 weeks
Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg
Measured: Up to 16 weeks
Proportional change from baseline in NT-proBNP and high-sensitivity troponin I
Measured: Up to 16 weeks
Proportional improvement in NYHA functional classification by 1 functional class
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start5 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Mar 2027 (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 Oregon Health and Science UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study where patients will transition from mavacamten to aficamten following a standardized protocol
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Lukes Hospital Mid America Heart Institute, Cytokinetics
- Responsible party
- Principal investigator, Ahmad Masri, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600177
- Sponsor's protocol ID
- STUDY00029878
- Other IDs
- 007119
- Acronym
- CMI-SWITCH
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07600177
- Acronym / sponsor ID
- CMI-SWITCH / STUDY00029878
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- aficamten, mavacamten, cardiac myosin inhibitor, CMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Saint Lukes Hospital Mid America Heart Institute, Cytokinetics
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 May 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 is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study where patients will transition from mavacamten to aficamten following a standardized protocol
| Arm | Type | Receives |
|---|---|---|
| CMI | Experimental | Drug: AficamtenSwitching from mavacamten on day 1 to aficamten starting at week 2. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented history of oHCM with documented resting and/or Valsalva LVOT obstruction ≥ 50 mmHg who are currently receiving mavacamten commercially.
- Echo-derived LVEF ≥55% on mavacamten at the time of enrollment.
- Patient willing to consent for the study and undergo the study procedures.
Key exclusion criteria (6 listed)
- Severe aortic stenosis or sub-aortic obstruction
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- History of LVEF <30%.
- Paroxysmal atrial fibrillation (AF) with documented episode within 3 months.
- Atrial fibrillation (paroxysmal or permanent) not on systemic anticoagulation.
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 |
|---|---|---|
| AficamtenPatients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later. | Drug | CMI |
Primary outcome
Safety Endpoints
Time frame: Up to 16 weeks
To describe the safety of this proposed protocol. These include: 1. Participant incidence of reported AEs 2. Participant incidence of reported SAEs 3. Participant incidence of LVEF < 40%
4 secondary outcomes
Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment
Time frame: Up to 16 weeks
Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg
Time frame: Up to 16 weeks
Proportional change from baseline in NT-proBNP and high-sensitivity troponin I
Time frame: Up to 16 weeks
Proportional improvement in NYHA functional classification by 1 functional class
Time frame: Up to 16 weeks
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 20 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aficamten in people with Hypertrophic Cardiomyopathy (HCM), run by Oregon Health and Science University at 2 sites in United States.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmad Masri (503-494-7551, masria@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints (time frame: Up to 16 weeks). 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 20 May 2026.