Tokyo, Nov. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059669) titled 'Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy' on Nov. 20.
Study Type:
Observational
Primary Sponsor:
Institute - KINDAI University
Condition:
Condition - Obstructive Hypertrophic Cardiomyopathy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the effects of mavacamten on coronary microcirculation in patients with symptomatic obstructive hypertrophic cardiomyopathy.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM)
Patients who meet the mavacamten administration criteria described in the 2025 revised Japanese Heart Failure Guidelines (those who continue to have NYHA functional class II-III symptoms despite pharmacological therapy with beta-blockers or calcium channel blockers)
Patients with a left ventricular ejection fraction (LVEF) >=55% at rest
Patients with a peak left ventricular outflow tract (LVOT) pressure gradient >=50 mmHg at rest, during Valsalva maneuver, or during exercise
Patients who have received a sufficient explanation regarding the purpose and details of this study, have fully understood it, and have provided written informed consent of their own free will
Key exclusion criteria - Patients with a history of resuscitation after cardiac arrest
Patients with a history of syncope, sustained ventricular tachycardia, or appropriate implantable cardioverter-defibrillator (ICD) intervention within the past 6 months
Patients who have undergone surgical septal myectomy or percutaneous transluminal septal myocardial ablation (PTSMA) within the past 6 months
Patients with a history of hypersensitivity to mavacamten, severe hepatic impairment (Child-Pugh class C), or who are pregnant or possibly pregnant
Patients who refuse to participate in the study or are deemed ineligible by the principal investigator
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 11 Day
Anticipated trial start date - 2025 Year 11 Month 20 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068255
Disclaimer: Curated by HT Syndication.