32 Clinical Trials for Various Conditions
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.
The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery. Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are: 1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery? 2. Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF? To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography. Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and considerable resources. Thus, careful patient selection is necessary to minimize risk for patients and maximize benefit for patients and society. Our long-term goal is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer alternatives to patients at increased risk for complications and (2) potentially, inform earlier LVAD implantation in patients with weakening right ventricular function.
Secondary hyperaldosteronism and the non-osmotic release of arginine vasopressin (AVP) are the major factors in sodium and water retention in pulmonary arterial hypertension with right ventricular failure. Natriuretic doses of mineralocorticoid antagonist and aquaretic doses of V2 receptor antagonist will attenuate the sodium and water retention respectively, and be associated with clinical improvement.
The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.
The goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.
Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury.
The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single right ventricle systemic pumps. This procedure has the potential to foster a new strategy for congenital heart patients. This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related serious adverse events and 2) monitor changes in cardiac structure and function.
Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.
The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will: * decrease the number of hospital and clinic visits due to heart failure symptoms * extend life * delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)
The primary purpose of this study is to learn if taking pictures of your heart using two dimensional and three dimensional echocardiography in the heart failure intensive care unit can be helpful to understanding how the heart is working. All research subjects will be adults admitted to the heart failure ICU with acute decompensated heart failure and requiring monitoring of their heart function using a catheter that is placed in the pulmonary artery which is a blood vessel. In this situation, use of the pulmonary artery catheter,or PAC, is considered standard clinical care. It is not a research procedure. The PAC would be used even if you were not participating in this research project. All research subjects will be evaluated at the time they are admitted to the ICU, 24 to 48 hours after admission to the ICU, and 7 days after leaving the ICU. At all three time points, we will be taking pictures of the heart using the two dimensional and three dimensional echocardiogram. Additionally, at each time-point, we will collect a blood sample of approximately two and a half tablespoons each time, and a urine sample. We will be testing the sample for biomarkers of heart failure which are proteins and enzymes specifically related to heart function. We will not be conducting any genetic research on the sample. Any extra blood from these research tests will not be saved for future research. We will also be looking at the data that is collected by the pulmonary artery catheter. The catheter has a sensor on it that measures things like blood flow and pressure in the heart. At the Day 7 post discharge visit there will be a six minute hall walk so that we can access the distance that you can walk. We will access any symptoms that you may experience. A nurse or physician will monitor the six minute hall walk. The research information that we collect on you will not be placed in your medical record. The data is for research purposes only.
This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.
The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction \[HFrEF\], heart failure with preserved ejection fraction \[HFpEF\]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.
The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.
This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life. The specific questions that this study aims to answer are: 1. What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD? 2. Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients? In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function. The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.
This study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholds(DFTs), and that they may have long term advantages in reducing left ventricular dysfunction.
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis. There is increased risk for cardiovascular disease and higher propensity for cardiovascular related mortality among Black and non-Hispanic White patients. Recently, advanced cardiac imaging has become a vital tool in diagnosis and risk stratification of cardiovascular disease. Very limited data is available on the prevalence and characteristics of different cardiovascular diseases in Hispanic and African American minority groups, therefore, studying different racial and ethnic minority groups in the Bronx population is an exceptionally valuable source to determine the prevalence of cardiomyopathies among minority groups along with study survival in this population. This study aims to determine the etiology of cardiovascular disease in a diverse patient population by utilizing various cardiovascular imaging modalities, with a focus on cardiac magnetic resonance (CMR) imaging and to develop risk stratification models by applying advanced cardiovascular imaging markers.
This is a Phase 2, single-center, randomized placebo controlled trial of valsartan (an angiotensin receptor blocker) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of valsartan.
The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function, especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet") and lung recruitment maneuver (LRM) plus PEEPdec titration based on the best compliance of the respiratory system("PEEPLRM").
The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.
The purpose of this study is to find out if spironolactone added to ambrisentan for Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart pumps every minute), right ventricle function and quality of life.
This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies.
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.