This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups:
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups: Group 1: Mavacamten monotherapy Group 2: Mavacamten + Radiofrequency Ablation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Radiofrequency Ablation is a minimally invasive interventional technique performed via catheter guidance. It utilizes thermal energy (50-80°C) generated by high-frequency alternating current (typically 300-750 kHz) to induce coagulative necrosis or electrophysiological isolation in targeted tissues, thereby eliminating abnormal electrical activity or mechanical obstruction. In the treatment of cardiomyopathy, RFA is applied to ablate hypertrophied myocardial tissue (e.g., the ventricular septum) to alleviate left ventricular outflow tract (LVOT) obstruction.
Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
Time frame: from baseline to week 30
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 30mmHg.
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 30mmHg.
Time frame: At week 30
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 50 mm Hg.
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 50 mm Hg.
Time frame: At week 30
The proportion of patients at week 30 at least 1 class improvement in NYHA functional classification.
The proportion of patients at week 30 at least 1 class improvement in NYHA functional classification.
Time frame: Changes from baseline to week30 in the resting LVOT peak gradient
Changes from baseline to week30 in the resting LVOT peak gradient.
Changes from baseline to week30 in the resting LVOT peak gradient
Time frame: from baseline to week 30
Changes from baseline to week 30 in the KCCQ Clinical Summary Score (KCCQ-CSS)
Changes from baseline to week 30 in the KCCQ Clinical Summary Score (KCCQ-CSS),
Time frame: from baseline to week 30
Changes from baseline to week 30 in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level.
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Changes from baseline to week 30 in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level
Time frame: from baseline to week 30
Changes from baseline to week 30 in the high-sensitivity cardiac troponin I (hs-cTnI) level.
Changes from baseline to week 30 in the high-sensitivity cardiac troponin I (hs-cTnI) level.
Time frame: from baseline to week 30.
Changes from baseline to week 30 left of the ventricular mass index (LVMI) evaluated by CMR imaging.
Changes from baseline to week 30 left of the ventricular mass index (LVMI) evaluated by CMR imaging.
Time frame: from baseline to week 30
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: from baseline to week 30