Aficamten and Patient-Reported Outcomes in Real-World nHCM

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively observing changes in symptoms, biomarkers, imaging findings, and adverse reactions, etc. It will also record the dosing regimens at which individual patients achieve steady state, and explore the treatment patterns of Aficamten in Chinese patients with symptomatic nHCM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-85 years.

Left ventricular wall thickness ≥15 mm at any site on echocardiography or cardiac magnetic resonance.

Left ventricular wall thickness ≥13 mm in individuals testing positive for a pathogenic variant or in genetically affected family members.

Ventricular wall thickening caused by other cardiovascular diseases or systemic or metabolic disorders has been excluded.

Disqualifiers

LVOTG ≥30 mmHg at rest and/or with provocation.

LVEF <50% on transthoracic echocardiography.

Symptomatic hypotension or systolic blood pressure (SBP) <100 mmHg.

Severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or currently receiving blood purification therapy.

Trial population

Patients with symptomatic non-obstructive hypertrophic cardiomyopathy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • receiving aficamten

    Drug

    Aficamten will be administered at a specified dose according to each patient's tolerability, as assessed by echocardiography.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Aficamten group1 intervention

Trial outcomes

Primary outcomes

1

Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS

Time frame
From enrollment to the end of treatment at 24 months

Secondary outcomes

1

Absolute change from baseline in NT-proBNP

Time frame
From enrollment to the end of treatment at 24 months
2

Percentage change from baseline in TnT/TnI

Time frame
From enrollment to the end of treatment at 24 months
3

Absolute change from baseline in TnT/TnI

Time frame
From enrollment to the end of treatment at 24 months
4

Absolute change from baseline in maximal wall thickness (MWT)

Time frame
From enrollment to the end of treatment at 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: