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Cardiomyopathy, Hypertrophic clinical trials

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NCT ID: NCT04770142 Recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

Start date: April 20, 2021
Phase: N/A
Study type: Interventional

Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.

NCT ID: NCT04684290 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy

AMARONE
Start date: June 30, 2021
Phase: N/A
Study type: Interventional

The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).

NCT ID: NCT04649034 Recruiting - Stroke Clinical Trials

Intraventricular Stasis In Cardiovascular Disease

ISBIFLOW
Start date: November 24, 2020
Phase:
Study type: Observational

This study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke (ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy) by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis.

NCT ID: NCT04470102 Recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

PRIZMA-pilot
Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

NCT ID: NCT04464655 Recruiting - Clinical trials for Coronary Artery Disease

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Start date: December 12, 2019
Phase:
Study type: Observational

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

NCT ID: NCT04426578 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Role of Perhexiline in Hypertrophic Cardiomyopathy

RESOLVE-HCM
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Hypertrophic Cardiomyopathy (HCM) is the most common inherited heart muscle condition affecting up to 1 in 200 of the general population. It results from mutations in genes encoding components of the contractile apparatus in the heart muscle cell (myocyte). These mutations result in increased energy cost of force production for the myocyte which then cumulatively causes a myocardial energy deficit. This myocardial energy deficit is then thought to lead to cardiac hypertrophy ('left ventricular hypertrophy' or LVH) in HCM. LVH leads to impairments in heart muscle function, heart muscle oxygenation and microvascular blood flow and is the chief driver of patient symptoms in HCM. These symptoms consist of chest pain, shortness of breath, dizziness, fainting episodes or palpitations. Occasionally, the disease may cause sudden cardiac death (SCD). HCM is the most common cause of SCD in young people including competitive athletes. In addition, HCM has been found to result in significant global deterioration in health-related quality of life. Treatment of HCM has focused on relief of symptoms by drugs such as ß-blockers which slow the heart rate and improve heart function. However, symptom relief is often incomplete and there is no evidence on the benefit of ß-blockers or related medications to reverse LVH. Perhexiline, a potent carnitine palmitoyl transferase-1 (CPT-1) inhibitor shifts myocardial metabolism to more efficient glucose utilisation and rectifies impaired myocardial energetics. It is currently used to treat angina in patients with coronary artery disease. There is some preliminary evidence that Perhexiline may aid in the improvement of symptoms in patients with HCM. However, the effect of any form of therapy on potential regression of LVH in HCM remains unexplored. In this randomised double-blind placebo-controlled trial, the investigators will use state of the art cardiac imaging, principally advanced echocardiography and Cardiovascular Magnetic Resonance (CMR) to study the effects of perhexiline on LVH, cardiac function, and oxygenation in symptomatic patients with HCM. The investigators hypothesize that perhexiline will favourably reduce LVH and improve myocardial oxygenation by improving myocardial energetics, and that these putative morphological and functional changes can be accurately measured utilizing echocardiography and CMR. If this pilot study supports the hypothesis, then it will pave the way for a major randomised controlled trial to definitely determine the role of Perhexiline in HCM.

NCT ID: NCT04355260 Recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

The Clinical Research of the Safety and Effectiveness Evaluation for Using Echocardiography-guided Liwen RF Radiofrequency Ablation System to Treat Hypertrophic Obstructive Cardiomyopathy

Start date: July 30, 2019
Phase: N/A
Study type: Interventional

Objective to investigate the safety and effectiveness of Echocardiography-guided radiofrequency ablation in patients with Hypertrophic obstructive Cardiomyopathy (HOCM). Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a safe and effective treatment approach for Hypertrophic obstructive Cardiomyopathy and results in sustained improvement in exercise capacity, persistent in reducing Left Ventricle Outflow Tract (LVOT) gradient, and sustained improvement in cardiac function. In patients with disabling symptoms caused by Hypertrophic obstructive Cardiomyopathy (HOCM),Echocardiography-guided radiofrequency ablation could be a less invasive treatment option. Percutaneous intramyocardial septal radiofrequency ablation (Liwen Procedure) is a new method for the diagnosis or treatment of heart disease by using a special diagnosis and treatment device to the heart target area under the guidance of image technology. The method breaks through the worldwide problem of the minimally invasive diagnosis and treatment of the myocardium on the beating heart, so as to avoid the X-ray radiation and contrast agent damage . As a new pathway of cardiac disease intervention, Liwen Procedure can be used in congenital heart disease, myocardial biopsies, drug injection, cell implantation and instrument implantation in addition to Hypertrophic Cardiomyopathy and cardiac tumors. It has important clinical value and broad application prospect. In this study, Liwen RF radiofrequency ablation system was used to treat HOCM , and evaluate its safety and effectiveness , in order to provide a new medical device for Liwen Procedure of HOCM.

NCT ID: NCT04265040 Recruiting - Amyloidosis Clinical Trials

DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies

TORCH-Plus
Start date: August 18, 2020
Phase:
Study type: Observational [Patient Registry]

The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity. This DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. "Clinical phenotyping, follow-up & biosampling" 2. "Genomics", 3. "Inflammation" and 4. "Biomarker". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.

NCT ID: NCT04230551 Recruiting - Clinical trials for Remodeling, Ventricular

Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

RASTA
Start date: January 21, 2020
Phase: N/A
Study type: Interventional

Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients. The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

NCT ID: NCT04157205 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy

PREDICTVFII
Start date: November 10, 2019
Phase: N/A
Study type: Interventional

Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision. The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with (HCM) who have also survived a life-threatening event. This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.