View clinical trials related to Cardiomyopathy, Hypertrophic.
Filter by:This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating: 1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction; 2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this study were treated. After signing an informed consent form, subjects are enrolled and treated with the DragonFire Transcatheter Myocardial Ablation System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, and 12 months after the procedure.
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.
The index of microcirculatory resistance (IMR) serves as an indicator of coronary microvascular dysfunction (CMD) with significant prognostic value in various clinical conditions. However, its impact on CMD in the hypertrophic cardiomyopathy (HCM), whether assessed invasively or non-invasively, is yet to be investigated. We assessed the prognostic importance of CMD using less invasive coronary angiography-derived IMR (caIMR) in HCM patients with nonobstructive epicardial coronary arteries.Patients with HCM who underwent invasive coronary angiography for suspected myocardial ischemia were included. Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR>25U, in line with prior research, and the primary study endpoint was major adverse cardiac events (MACE).
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
The purpose of this study was to understand the epidemiological status of Fabry in patients with hypertrophic cardiomyopathy or left ventricular hypertrophy through multi-center early identification of high-risk patients in cardiology according to high-risk profiles, supplemented by DBS (dried blood disc) screening tools, and to explore the screening and diagnosis methods of patients with Fabry disease in cardiology, so as to promote the early identification, diagnosis and treatment of Fabry in cardiology.
This study is designed to rigorously evaluate the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) as an innovative, non-invasive treatment for Hypertrophic Obstructive Cardiomyopathy (HOCM). HOCM, a prevalent cardiac condition, is primarily characterized by asymmetric septal hypertrophy, which results in the obstruction of the left ventricular outflow tract. This obstruction significantly compromises patient quality of life and is associated with severe risks, including arrhythmias and sudden cardiac death. While current treatments like medications, surgical septal myectomy, and percutaneous transluminal septal myocardial ablation (PTSMA) have proven to be effective, they are not without limitations. SBRT, a recent development in non-invasive cardiac radioablation, has shown encouraging results in early-stage studies, suggesting its potential as a safe and feasible option for HOCM treatment. In this study, participants will be randomly assigned to either the SBRT treatment group or a control group receiving a sham procedure. The primary objective is to measure the change in the left ventricular outflow tract pressure gradient under provoked conditions, using cardiac ultrasound at a 6-month follow-up. This will provide a clear assessment of the direct impact of SBRT on the primary physiological complication of HOCM. The study also sets forth several secondary objectives to provide a holistic view of the treatment's impact. These include evaluating changes in NYHA functional classification and KCCQ scores to assess improvements in symptom severity and quality of life, respectively. Additionally, we will monitor physical capacity through the 6-minute walk test, and biomarkers like NT-proBNP and cTNT for cardiac stress and damage. The effect of SBRT on QRS duration will be analyzed to understand its impact on cardiac electrical activity. The incidence of major adverse cardiac events (MACEs) within 6 months post-treatment will be recorded to evaluate safety, and the need for invasive septal reduction therapy post-treatment will be assessed to gauge long-term efficacy. This study aims to provide a comprehensive understanding of the potential of SBRT as a treatment alternative for HOCM. By comparing its outcomes with those of traditional therapies, the study seeks to establish SBRT's role in symptom alleviation, quality of life enhancement, and risk reduction in HOCM management.
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York Heart Association (NYHA) Functional Class II or III].