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RecruitingNCT07600177CMI-SWITCHUpdated May 20, 2026

Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy

A Phase 4 interventional study of Aficamten in Hypertrophic Cardiomyopathy (HCM), sponsored by Oregon Health and Science University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Oregon Health and Science University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hypertrophic Cardiomyopathy (HCM)

Keywords

  • aficamten
  • mavacamten
  • cardiac myosin inhibitor
  • CMI
03

In context

Cardiomyopathy, Hypertrophic

347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.

This study's planned enrollment of 40 is below the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CMI

    Switching from mavacamten on day 1 to aficamten starting at week 2.

    Drug: Aficamten

Interventions

  • DrugAficamten

    Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.

06

What researchers measure

Primary outcomes

  1. Safety Endpoints

    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%

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment

    Time frame: Up to 16 weeks

  2. Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg

    Time frame: Up to 16 weeks

  3. Proportional change from baseline in NT-proBNP and high-sensitivity troponin I

    Time frame: Up to 16 weeks

  4. Proportional improvement in NYHA functional classification by 1 functional class

    Time frame: Up to 16 weeks

07

Study locations

1 of 2 sites recruiting
  • St. Luke's Hospital - Mid America Heart Institute
    Kansas City, Missouri 64111, United States
    • Michael Nassif, MD · Contact · mnassif@saint-lukes.org · 816-932-3458
    • Michael Nassif, MD · Principal investigator
    Not yet recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07600177
Lead sponsor
Oregon Health and Science University
Collaborators
Saint Lukes Hospital Mid America Heart Institute, Cytokinetics
Responsible party
Ahmad Masri (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted
May 20, 2026
Start date
May 5, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Ahmad Masri
Contact
masria@ohsu.edu
503-494-7551

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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