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NCT Number: NCT07600177

Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy

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).

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Key information

Conditions

Hypertrophic Cardiomyopathy (HCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's Hospital - Mid America Heart Institute, Kansas City, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aficamten

Drug

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

Primary outcomes

  1. Safety Endpoints

    Time frame: Up to 16 weeks

    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%

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Cytokinetics
  • Saint Lukes Hospital Mid America Heart Institute

Registry information

Acronym: CMI-SWITCH

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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