Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060066) titled 'A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten In Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Cibenzoline in Japan' on Feb. 1.

Study Type: Observational

Primary Sponsor: Institute - Bristol-Myers Squibb K.K.

Condition: Condition - Hypertrophic obstructive cardiomyopathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To assess the effectiveness of a 16-week course of mavacamten treatment in reducing the resting or Valsalva left ventricular outflow tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = 15 mm (or >= 13 mm with positive family history of HCM). ii.Has LVOT peak gradient >= 30 mmHg (resting, Valsalva maneuver, or post-exercise). 3.Has documented LVEF >= 55% at baseline. 4.Patients who meet any of the following criteria: i.Patients who have previously received mavacamten continuously for >= 16 weeks ii.Patients who are currently receiving mavacamten iii.Patients who are scheduled to receive mavacamten 5.Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering. 6.At least 18 years of age at the time of signing the informed consent. Key exclusion criteria - 1.Hypersensitivity to the active substance or to any of the excipients. 2.During pregnancy and in women of childbearing potential. 3.Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol). 4.Severe hepatic impairment (Child-Pugh C). 5.Severe atrioventricular block or severe sinoatrial block. 6.Congestive HF. 7.Requiring dialysis. 8.Angle-closure glaucoma. 9.Tendency to urinary retention. 10.Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate. 11.Mavacamten treatment within 8 weeks prior to baseline. 12.Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient. Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 07 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068695

Disclaimer: Curated by HT Syndication.