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Cardiomyopathy, Hypertrophic clinical trials

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NCT ID: NCT01537926 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Hypertrophic Regression With N-Acetylcysteine in HCM

HALT
Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of the sudy is to conduct a small study to gather the preliminary data for future lage scale clinical studies that will be designed test the potential beneficial effect of over-the counter study anti-oxidant drug called N-acetylcysteine (NAC) in patients with a heart muscle condition called Hypertrophic Cardiomyopathy (HCM). The present study is a pilot feasibility study, the investigators want to find out whether the investigators can recruit and retain patients with HCM in the study and whether these patients can tolerate this drug and can stay on one year. Likewise, the investigators want to find out any potential side effects that this drug might have and estimate whether it has any beneficial effects.

NCT ID: NCT01447654 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy

INHERIT
Start date: November 2011
Phase: Phase 2
Study type: Interventional

Objective The objective of the study is to assess the structural and functional cardiac effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM). Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on individuals with borderline hypertrophy will be analysed separately from the rest of the cohort. Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall thickness.

NCT ID: NCT01334801 Completed - Aortic Stenosis Clinical Trials

Biomarkers in Aortic Stenosis - B.A.S.S.

BASS
Start date: July 2010
Phase:
Study type: Observational [Patient Registry]

This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

NCT ID: NCT01198899 Completed - Clinical trials for Left Ventricular Hypertrophy

Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy

Start date: July 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study is a screening study

NCT ID: NCT01160536 Completed - Clinical trials for Cardiovascular Disease

The Perceived Impact of Children s Risk Status for Hypertrophic Cardiomyopathy on Families: an Exploratory Study

Start date: June 24, 2010
Phase:
Study type: Observational

This study proposes to describe how children s hypertrophic cardiomyopathy (HCM) risk status affects family functioning, behaviors, and relationships. HCM is the most common inherited cardiovascular single-gene disorder. Individuals with HCM may experience shortness of breath, chest pain, palpitations, dizziness, syncope, heart failure, and arrhythmias predisposing to sudden cardiac death at any age. Notably, HCM is the most common cause of sudden cardiac death in people under 30 years of age. Genetic testing can identify at-risk individuals; however, the impact of potentially life-altering genetic information on families remains largely unexplored. Increasingly, health care providers are providing the testing in children for conditions like HCM that are life-threatening and medically manageable without the benefit of understanding the psychological consequences. The few studies that have been conducted suggest that genetic testing in children may result in changes to family relationships, parental emotional wellbeing, parenting behaviors, and child functioning in a subset of children. One synthesis of these studies suggests that children as a group show little evidence for maladjustment to risk information, but that parents are affected by the carrier status of their children. The proposed study intends to further this body of knowledge by exploring the impact of children s risk status on families with HCM. Health care providers and researchers can inform their work with HCM families by better understanding the potential impact of genetic risk as an important component of families adaptation to the life-threatening information about their children. The families targeted for this exploratory study will be purposively sampled from those that have been aware of the children s risk status or not at-risk status for HCM for at least 3 months. The cross-sectional design is composed of semi-structured interviews with a parent and, separately, with his/her 13 to 23 year-old child who is either a carrier for HCM, a non-carrier, or at 50% risk for being a carrier. The interview will target issues related to the perceived impact of the child s risk status on family functioning, parenting behaviors and relationships. Data from the parent-child dyads will be analyzed for concordance/discordance along parallel themes. The results of this study may facilitate the understanding of the perceived impact of learning children s HCM risk status, which will inform both clinical care and future research. Importantly, since predictive testing in children for adult-onset diseases is generally discouraged, very little is actually known about its impact on families. Therefore, the study of this unique subgroup of an HCM population that uses clinically indicated predictive testing in childhood offers a preliminary opportunity to learn about predictive testing of minors....

NCT ID: NCT01150461 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

Start date: February 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle scarring.

NCT ID: NCT01127061 Completed - Clinical trials for Cardiomyopathy, Hypertrophic

Study of Exercise Training in Hypertrophic Cardiomyopathy

RESET-HCM
Start date: April 2010
Phase: N/A
Study type: Interventional

The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption (peak VO2) and quality of life, with neutral effects on the clinical characteristics.

NCT ID: NCT01081093 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

BIVENT
Start date: April 2010
Phase: N/A
Study type: Interventional

Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure. A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure. The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.

NCT ID: NCT00879060 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy

Start date: November 2007
Phase: Phase 4
Study type: Interventional

Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular states in which aldosterone production is increased. In HCM, aldosterone production is up-regulated and has been implicated in the formation of myocardial fibrosis. Therefore, the specific aims of this proposal are to: 1. assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters 2. examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters. 3. explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR. The results of this proposal will offer important insights into the clinical significance of myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that spironolactone decreases fibrosis and improves clinical course would provide the rational for a larger multicenter clinical trial evaluating this novel therapy for improving clinical outcome in patients with HCM.

NCT ID: NCT00821353 Completed - Atrial Fibrillation Clinical Trials

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Start date: January 2009
Phase: Phase 3
Study type: Interventional

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome. Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients. Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.