26 Clinical Trials for Various Conditions
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.
The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.
Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components).
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advanced heart failure. Using a 2x2x2x2 factorial design, 64 adults with advanced heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
In order to determine if NfL can be a prognostic biomarker for VCID, participants will undergo a baseline evaluation consisting of neuropsychological testing and a blood draw with a 12-month follow-up consisting of neuropsychological testing and blood draw. After indicated interest in the study, participants will be screened either in person during a regularly scheduled clinic visit or by phone for eligibility. After consenting, participants will be scheduled for a baseline testing session. One session, lasting about 3 hrs, will include neuropsychological testing and a blood draw. After completion of baseline testing, participants who agree to take part in the clinical trial will begin a 12-week treatment of Ang-(1-7) via daily subcutaneous injections. During the drug treatment, participants will be called weekly to ensure that everything is going well with the injections. After participants have completed the 12-week injection period, participants will be scheduled for a second appointment which will include a blood draw and neuropsychological testing. All participant will be scheduled for a 12-month follow-up, which will include a blood draw and neuropsychological testing. Participants will be called every second month by research staff for a brief update on changes to health status, and to increase compliance with the 12-month follow-up. Our One-Year outcome for this study is to provide early proof-of-concept clinical trial data that will support a larger, more comprehensive NIH funded study on the safety and efficacy of Ang-(1-7) to prevent cognitive impairment in HF patients at risk for developing VCID/ADRD. Our Long-Term outcome is to demonstrate whether plasma NfL exhibits characteristics making it useful as a Prognostic Biomarker to predict cognitive decline in early heart disease-associated VCID and identify pre VCID-symptomatic in individuals with symptomatic HF. Our goal will be to use levels of plasma Nfl as an enrollment enrichment factor in future trials to allow enrollment or stratification of patients more likely to develop VCID or ADRD and be responsive to Ang-(1-7) therapy.
Preliminary animal studies by ourselves and others suggest that the dietary supplement, nicotinamide riboside (NR), may improve cardiac function in heart failure (HF) by increasing cellular levels of its metabolite, nicotinamide adenine dinucleotide (NAD+, NADH). This Study will address a key gap in current knowledge by assessing the mechanisms through which raising blood and myocardial NAD+ levels in humans mediates changes in mitochondrial function, protein and epigenetic modifications, as well as inflammation. Human myocardium will be obtained after 4-14 days of oral NR supplementation from advanced heart failure patients undergoing elective left ventricular assist device (LVAD) implantation. Positive results would provide evidence to proceed with further studies of NR as a mitochondria-targeted metabolic therapy in heart failure.
The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first study to apply low-intensity exergaming to a pre-operative advanced HF/MCC population. The successful application of this intervention has significant implications to the pre-operative conditioning of individuals with advanced HF/MCC prior to LVAD implantation or OHT.
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation. The goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.
The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.
The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood. This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization. The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.
This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).
The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient population that is reflective of current heart failure treatment practice.
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software. This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method. This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.