Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy

NCT07600177 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY00029878007119
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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)

Keywords

aficamten; mavacamten; cardiac myosin inhibitor; CMI

Outcome Measures

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%

  Up to 16 weeks

Secondary Outcomes (4)

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

  Up to 16 weeks

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

  Up to 16 weeks

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

  Up to 16 weeks

• Proportional improvement in NYHA functional classification by 1 functional class

  Up to 16 weeks

Study Arms (1)

CMI

EXPERIMENTAL

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

Drug: Aficamten

Interventions

Aficamten DRUG

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

CMI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Saint Lukes Hospital Mid America Heart Institute: collaborator
• Cytokinetics: collaborator

Study Sites (2)

St. Luke's Hospital - Mid America Heart Institute

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Ahmad Masri

CONTACT

503-494-7551; masria@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single group study where patients will transition from mavacamten to aficamten following a standardized protocol

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)