Treatment Trials

5 Clinical Trials for Various Conditions

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COMPLETED
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
Description

The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.

RECRUITING
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
Description

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

TERMINATED
Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease
Description

The aim of this project is assess a non-invasive functional liver tests in patients with the Fontan circulation that may be used for prognostic purposes. Specifically, we aim to determine whether there are alterations in Methacetin Breath Test (MBT) in the Fontan patient and if so, whether it is related to conventional tests of liver and cardiac function. The hypothesis is that MBT CPDR 20 in the Fontan patient is abnormal as a result of alterations in liver perfusion, liver cell metabolic capability and transhepatic resistance secondary to hemodynamics unique to the Fontan as well as end-organ liver damage. Due to lack of robust biomarkers or other risk stratification schemes, we aim to determine whether there is prognostic value in hepatic MBT CPDR 20 in the Fontan patient. Aims - The aims of this study are three-fold: 1. To measure MBT parameter in a cohort of patients with Congestive (Dilated) Cardiomyopathy and a group of Fontan patients and compare results to published normal controls. 2. To explore any association between MBT parameter and clinical parameters already available, including Fontan hemodynamics as assessed by either of the following tests: cardiac catheterization, echocardiography, non-invasive imaging of the liver (CT or MRI), non-invasive assessment of liver stiffness (ARFI, MRE or Fibroscan), laboratory investigations, and clinical characteristics (i.e. age of patient, time since Fontan operation, type of Fontan etc.) within 12 months of the study. 3. To determine whether MBT is predictive of clinical outcomes: heart failure, clinically significant ascites, and time to transplant or death.

TERMINATED
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Description

The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease. The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor. Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.

COMPLETED
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
Description

In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.