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Cardiomyopathy, Hypertrophic clinical trials

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NCT ID: NCT06256913 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy

2022PI172
Start date: May 6, 2023
Phase:
Study type: Observational

Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure. The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.

NCT ID: NCT06253221 Recruiting - Clinical trials for Cardiomyopathy, Hypertrophic

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Start date: April 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

NCT ID: NCT06224621 Recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06181617 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan

Start date: December 6, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT06169358 Recruiting - Fabry Disease Clinical Trials

Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy

SEARCH
Start date: October 1, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT06167876 Recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy

SAFECARE
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06116968 Recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT06112743 Recruiting - Clinical trials for Cardiomyopathy, Hypertrophic

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

MEMENTO
Start date: January 24, 2024
Phase: Phase 4
Study type: Interventional

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].

NCT ID: NCT06081894 Recruiting - Clinical trials for Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

ACACIA-HCM
Start date: August 30, 2023
Phase: Phase 3
Study type: Interventional

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

NCT ID: NCT06078410 Recruiting - Clinical trials for Transapical Beating-Heart Septal Myectomy

Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy. The main questions are: whether this novel operation way would cause neurologic impairment; whether this novel operation way have similar neurologic lesions, compared to other cardiac surgery ways. Participants will undergo detailed neurologic and cognitive assessment at baseline, after procedure, and at 30 days. Researchers will compare the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e. Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) to assess the safety of transapical beating-heart septal myectomy on nervous system.