Recruiting

Mavacamten & Aficamten

Sponsor:

Oregon Health and Science University

Code:

NCT07600177

Conditions

Hypertrophic Cardiomyopathy (HCM)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Aficamten

Study Details

Brief 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).

Conditions

Hypertrophic Cardiomyopathy (HCM)

Study ID

NCT07600177

Start date

May 5, 2026

Status verified date

May, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CMI

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

Interventions

Aficamten

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

Primary outcome measure

  • Safety Endpoints [ Time Frame: Up to 16 weeks ]

Central Contacts and Locations

Central contacts

Ahmad Masri

503-494-7551masria@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ahmad Masri, MD

503-494-7551masria@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • aficamten
  • mavacamten
  • cardiac myosin inhibitor
  • CMI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-05-20.