View clinical trials related to Cardiomyopathies.
Filter by:This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment. Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients. Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies. Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines. Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.
This will be a cross-sectional, observational study. Null hypothesis: There is no difference in the amount of extracellular volume (ECV or scarring) in the hearts of patients with heart failure as compared to control subjects. Heart failure occurs when the heart muscle has become too weak to work properly. It is associated with an increase in the amount of connective tissue (collagen) which replaces dead heart muscle cells (scarring). Currently a biopsy of the muscle is the only way to measure the amount of scarring. This is invasive and rarely done in children. Because of this, it is difficult to measure the amount of scarring in a particular patient or disease process, which is important for improving our understanding and treatment of the disease. Cardiac magnetic resonance imaging (MRI) is a non-invasive imaging tool which is routinely used to look at areas of local scarring in heart muscle. Because the scarring is so widespread in paediatric patients, we have not been able to use this method previously. Now new imaging techniques allow us to look at widespread scarring but these have not yet been validated in children. We plan to use late gadolinium enhancement (T1 mapping) to measure the amount of scarring in patients with heart failure (we have evidence that their heart biopsies show increased amounts of scar tissue) and children having MRI scans for other reasons. We will use measures of function including echocardiography and 6 minute walk test to compare to the amount of scarring. This will help us to know whether the amount of scarring will be clinically useful. We will look at the amount of various proteins in the blood of patients and control subjects which are related to the scarring and cell death processes. We already use blood tests to monitor heart failure and these tests may help us to refine our testing and improve timing of treatment (e.g. transplantation). This study will help us to design further research in this field.
The ICD Registry™ is a nationwide quality program that helps participating hospitals measure and improve care for patients receiving implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillator (CRT-Ds). The ICD Registry captures the characteristics, treatments, and outcomes of patients receiving (ICDs). Patient-level data is submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's (ACCF) National Cardiovascular Data Registry (NCDR) which then produces an Outcomes Report of the hospital's data, with comparison to both a volume peer group (number of ICD patients submitted annually) and the entire ICD registry data set.
This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.
We hope to introduce a novel MRI contrast agent with SeeM ore ™ that directly defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is still a moving target and a question we plan to answer more definitively with the SeeMore ™ contrast. Though well tested. in small and large animals and Phase I & II clinical trials, we would like to determine the efficacy of the SeeM ore TM contrast further in a clinical setting. SeeM ore ™ is a new manganese (Mn)-based intravenous imaging agent being developed to enhance magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic and kinetic properties for MRI, use in humans was not initially possible due to cardiovascular depression and electrocardiogram (ECG)changes, including prolongation of PR and QTc intervals, associated with intravenous administration [1-5]. Chelation of Mn, as had been done with gadolinium for use with MRI, provided relevant safety, but sacrificed desirable magnetic and kinetic properties [6]. SeeM ore rM provides Mn in a form that maintains the desired magnetic and kinetic properties while overcoming the cardiovascular toxicity of Mn. SeeM ore rM is taken up into heart cells .(primarily via addition of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The potential to distinguish healthy heart tissue from unhealthy heart tissue based on a specific sustained pattern of enhancement provides a basis for evaluating the performance of SeeM ore rM in heart patients. MRI offers benefits over other imaging technologies. Relative to radioactive nuclear imaging procedures, MRI is 3-dimensional, provides good soft tissue discrimination, and is of high spatial and temporal resolution. These features have been reported to identify smaller defects (e.g., subendocardial infarcts) and match angiographic results more closely than other modalities such as SPECT [7,8]. It may be possible to enhance the utility of MRI for heart disease further through the use of an imaging agent that is specifically taken up into heart cells. SeeM ore rM is the only cardiac-specific agent being developed for this purpose. Unlike nuclear perfusion agents, SeeM ore rM is not radioactive and does not require special handling, shielding, transport or storage. In addition, the specific pattern of enhancement achieved in the heart muscle persists over time, offering potential .benefits over the nonspecific extracellular agents currently available for MRI or X-ray/CT procedures. This feature allows full use of the high resolution of MRI, since there is not a trade-off of high spatial resolution for temporal (first-pass) resolution. It is anticipated the features offered by SeeMore™ along with the high resolution, three dimensional attributes of MRI will result in higher accuracy than is available with other current modalities in practice, including stress echocardiograms, cardiac MRI using gadolinium contrast and nuclear studies such as SPECT and PET. This will be evaluated in this study and serve as the basis for pivotal registration studies. All components of SeeMore™ are USP and are approved for use as drugs in man, orally and/or intravenously. A summary of the Phase I safety and PK (pharmacokinetics)study are provided below. The Phase I study evaluated the safety and tolerance of SeeM ore ™ in humans, with special emphasis on cardiovascular safety, and assessed its PK profile.
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
This trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in Duchenne Muscular Dystrophy (DMD). Both drugs are known to be effective for the treatment of dilated cardiomyopathy. ACEi have been reported to delay the onset and progression of left ventricle dysfunction in children with DMD. Multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. ARBs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an ACEi. However, in DMD, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. Considering that both skeletal and cardiac muscles are major contributors of the disability of DMD, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic DMD patient.
Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of heart failure.
To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and renal (kidney) dysfunction.
The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.