Active clinical trials for "Cardiomyopathies"

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure

The main aim of the study is to determine whether intracoronary infusion of autologous bone marrow mononuclear cells can improve the ventricular function of patients with idiopathic dilated cardiomyopathy.Secondary end-points will be: To evaluate possible changes in patient functional capacity and to identify the biological characteristics of the bone marrow graft that might influence on functional recovery.

Myocardial iron overload is the leading cause of death in patients with beta-thalassemia major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces myocardial iron and improves cardiac function. However, the prognosis for TM patients with established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and 8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths, occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO is superior to DFO monotherapy.

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: assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters 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. 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.

The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status.

This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment. The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart. The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure. The data collected from the experimental devices will be compared to the results from standard tests. Patients will not have any of their therapies altered as part of this study.

Chagas disease (CD) is the major cause of disability secondary to tropical diseases in young adults from Latin America. In this region 20 million people are currently infected by T. cruzi, the etiologic agent for CD. In Colombia, 18 percent of the population live in CD endemic areas, 900,000 people are infected and over three million are at high risk of being infected. Heart failure due to Chagas cardiomyopathy (CCM) is the main clinical form of CD in Colombia. However, the incidence of CCM among T. cruzi infected people is unknown and the mechanisms that lead from infection to CCM are uncertain. Besides the poor prognosis of CHF due to Chagas disease, it is important to estimate the risk of complications and death in patient infected with T. cruzi Unfortunately, few clinical studies have addressed this issue. Most T. cruzi infected patients have mild or no clinical disease, however, the percentage of infected people that will develop detectable cardiac abnormalities is approximately 30 to 40 percent, but only 20 percent of them will develop symptomatic cardiac involvement. Like CHF from other causes, CHF due to CD responds to digital, diuretics and vasodilators therapy. Also, some studies have shown that angiotensin-converting enzyme (ACE) inhibitors improve survival in patients with moderate to severe CHF due to CD. Increased sympathetic drive results in an increased risk of cardiac arrhythmia and sudden death. Beta-adrenoreceptor antagonism seems to protect against the deleterious effects of chronic sympathetic stimulation. The effects of the selective beta-adrenergic receptor blocker Bisoprolol on cardiovascular mortality, hospital readmission due to progressive heart failure and functional status in patients with CHF secondary to CCM has not been explored to-date. To evaluate the benefit of Bisoprolol in CHF due to CCM, a cohort of T. cruzi seropositive patients will be selected from several institutions in Colombia. Patients will be classified according to a modified version of the Panamerican Health Organization recommendations for patients with CCM. Overall one year mortality in patients with CHF due to Chagas disease has been reported as 34 percent. However, one year mortality is only 3 percent in patients in NYHA functional class II, 27 percent in those in NYHA functional class III, and 62 percent among those in functional class IV (22). The sample size has been calculated assuming an event rate of 40 percent in two years in the placebo group, and using a 95 percent confidence level and power of 80 percent, we will need to recruit 250 patients per treatment arm to detect a reduction of 30 percent in the risk of the primary outcome. The event rate we have used to estimate sample size is similar to the expected two-year mortality in patients with CHF due to Chagas disease in NYHA functional class II. Therefore, the estimated sample size should be enough to measure significant changes in the composite primary outcome (death, HF hospitalizations, SMVT, SCD). The recruitment process will follow guidelines set out by the FCV Ethics Committee. Most participants will be recruited from the Chagas disease and the Heart Failure clinics located in Bucaramanga, Bogotá and Cucuta. During the pretreatment period an initial evaluation visit will be scheduled in which participants will sign consent forms, baseline measurements and tests will be conducted at the FCV including blood pressure measurements obtained with patients in the sitting and standing positions. Laboratory test such as twelve-lead ECG will be recorded in each patient. Left ventricular ejection fraction at rest will be determined by 2D echocardiography, using a modified Simpsons rule to calculate LV volumes. Quality of life questionnaire will be performed two weeks apart during baseline examination using the Minnesota living with heart failure questionnaire. Minimum of two 6-minutes corridor walk test once a week over a two-week period will be performed to measure the functional class. During the treatment period patients will be randomly assigned to receive double-blind Bisoprolol or placebo, initially taking a total daily dose of 2.5 mgrs qd. The dose will be increased every two weeks to 5 up to 7.5 and 10 mgrs qd (maximum maintenance dose). Follow-up assessment will include clinical check-up, and blood collection for future measurements of inflammatory reactants and markers. Quality of life measurements will be obtained at six months. Following the descriptive analysis we will compare the patient survival and hospitalization rates using Kaplan-Meier estimates and survival graphs. Cox regression will be used for the multivariate analysis of time to death and time to hospitalization. This analysis will allow us to explore the pattern of changes in patients with chronic heart failure due to Chagas disease such as the effect of beta-blockers in this special type of cardiomyopathy.