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Cardiomyopathies clinical trials

View clinical trials related to Cardiomyopathies.

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NCT ID: NCT00371891 Completed - Clinical trials for Coronary Arteriosclerosis

Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS)

Start date: September 2006
Phase: Phase 4
Study type: Interventional

Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. The purpose of this study is to see if MDCTCA can identify significant coronary artery disease as good as or better than conventional coronary angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6 hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using MDCTCA. The information gathered during the MDCTCA will be compared to the results of the scheduled conventional invasive coronary angiogram.

NCT ID: NCT00354328 Completed - Clinical trials for Myocardial Infarction

Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

Start date: May 27, 2005
Phase:
Study type: Observational

This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM). Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144 ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from echocardiograms and measures of left ventricular pressure obtained from patients in those studies will be analyzed in the current study to assess their influence on exercise capacity. No additional tests, treatments or other procedures are required. Information from this study may help in the development of improved drug treatments for HCM.

NCT ID: NCT00352209 Completed - Cardiomyopathy Clinical Trials

Cardiomyopathy Following Stem Cell Transplantation

Start date: May 2, 2006
Phase: N/A
Study type: Observational

This study will examine the incidence of cardiac complications, particularly cardiomyopathy, in patients who have undergone allogeneic (donor) stem cell transplantation at NIH. Cardiac complications in these patients are well documented. Most commonly, patients develop congestive heart failure or pericarditis after receiving high-dose cyclophosphamide, radiation, or other intensive chemotherapy regimens prior to the transplant. Most data in the medical literature suggest that the rate of serious cardiac complications is relatively low, at about 5 percent or less. Recently, a cluster of cases of significant cardiomyopathy in stem cell transplant patients at the NIH Clinical Center has prompted concern that the incidence of these complications is higher than that reported in the medical literature. This study will further define the incidence of cardiac problems, primarily focusing on cardiomyopathy, with the following objectives: - To define the incidence of cardiomyopathy in allogeneic stem cell transplant patients enrolled in National Cancer Institute (NCI) and National Heart, Lung, and Blood (NHLBI) protocols at the NIH Clinical Center - To document the presence or absence of various known or suspected risk factors for cardiomyopathy in the documented cases. The study consists of a chart review of patients who have had an allogeneic stem cell transplant on either an NHLBI or NCI protocol since 1999. This project is a first step in clarifying the cardiac complications following stem cell transplantation, their incidence, and characteristics of the patient populations. It will look at patient demographics, the characteristics of the cardiac complication, and known or suspected risk factors.

NCT ID: NCT00333827 Completed - Clinical trials for Dilated Cardiomyopathy

Cell Therapy In Dilated Cardiomyopathy

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

NCT ID: NCT00324402 Completed - Pregnancy Clinical Trials

Plasma Brain Natriuretic Peptide Levels in Pregnancy

Start date: August 2006
Phase:
Study type: Observational

To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.

NCT ID: NCT00323973 Completed - Clinical trials for Chronic Heart Failure

Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity

Start date: July 2003
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00321295 Completed - Clinical trials for Heart Failure, Congestive

Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery

Start date: August 2004
Phase: Phase 3
Study type: Interventional

Congestive heart failure (CHF) is a medical condition that is due to left ventricular systolic dysfunction (LVSD). LVSD is a decreased ability of the heart to pump blood forward. There are 5 million people in the United States that have CHF and 52,828 new cases are diagnosed annually. There are 995,000 hospital visits and 52,828 deaths annually due to CHF. Previous studies have shown that people with this condition are at a higher risk for complications immediately after any type of heart surgery than are normal individuals. This includes increased dependence on medications and devices to improve the pumping function of the heart and blood pressure. Additionally, they also have longer lengths of hospital stay and higher rates of death compared to normal individuals. Some patients with LVSD not only have a decreased pumping ability of the heart, they also have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing involves simultaneously electrically stimulating the two major pumping chambers of the heart known as ventricles using a pacemaker and wires. This causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Studies have confirmed that in these patients, implantation of a biventricular pacemaker improves patients' symptoms and quality of life as well as decreasing a need for future hospitalizations. Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated. Some patients temporarily develop slow heart rates after cardiovascular surgery. These slow heart rates can cause a decrease in the blood pumped from the heart and result in low blood pressures. Therefore, all patients undergoing cardiovascular surgery, regardless of left ventricular function, receive temporary pacing wires that are placed on one of the ventricles during the surgery. Temporary pacing will result in an increase in heart rate and improvement in the amount of blood pumped by the heart and in blood pressure. The placement of these wires is precautionary as only a few patients need to be paced for slow heart rates. Once patients are felt to no longer require them, the wires are easily removed. The purpose of this study is to determine whether biventricular pacing immediately after heart surgery in patients with LVSD will improve in-hospital outcomes. Patients that are scheduled for heart surgery and meet the inclusion criteria will be approached for consent to participate in this study. Once consented, they will be randomized to one of three treatment arms: usual care, RV pacing (single ventricle pacing), or biventricular pacing. Randomization is a process similar to picking numbers out of a hat. The patients will then undergo surgery as scheduled. During the surgery, the patients will receive the temporary pacing wires on both ventricles instead of one. Immediately after surgery, the patients will receive either usual care, RV pacing, or biventricular pacing depending upon the treatment arm that they were randomized to. The pacing wires will be removed as soon as the patients become stable as per routine. The clinical, operative, and in-hospital characteristics of these patients will be recorded on specialized forms. The characteristics of those that received biventricular pacing will be compared to those that had RV or no pacing to see whether there was any benefit to this mode of therapy.

NCT ID: NCT00319982 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

Start date: January 2006
Phase: Phase 2/Phase 3
Study type: Interventional

This is a pilot clinical trial to assess whether the administration of diltiazem may be able to decrease the development or progression of hypertrophic cardiomyopathy (HCM). Diltiazem is a commonly used medication for the treatment of high blood pressure and studies on animals with HCM suggest that diltiazem decreases disease development. This study specifically targets individuals in the "prehypertrophic" phase of HCM-- those with documented sarcomere gene mutations without echocardiographic or EKG evidence of LVH, and therefore without a clinical diagnosis of HCM. The hypothesis of this study is that starting diltiazem administration early in life (in the prehypertrophic phase) will decrease the progression of HCM in individuals with sarcomere gene mutations. This will be assessed by looking at an improvement in the heart's ability to relax using echocardiography, as well as exploratory analyses of a broad range of features reflecting the heart's structure and function.

NCT ID: NCT00317967 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the Heart

Start date: April 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if a drug called atorvastatin will reduce the size and stiffness of the muscle in the left ventricle of the heart.

NCT ID: NCT00312624 Completed - Cardiomyopathy Clinical Trials

Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies

Start date: April 2006
Phase: N/A
Study type: Observational

This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence of ICD therapy.