View clinical trials related to Transplant; Failure, Heart.
Filter by:The goal of this clinical trial is to test if SGLT2 inhibitors could prevent or delay the development of Cardiac Allograft Vasculopathy (CAV) post-heart transplantation (TxC). The main questions it aims to answer are: Primary outcome: CAV, according to ISHLT grading system diagnosed by CCTA; Secondary outcomes: cardiovascular death, all-cause mortality, hospitalization, worsening glomerular filtration rate, fasting glucose, weight, and blood pressure. Exploratory and safety outcomes: Rejection, hypoglycemia, urinary tract infection, hypovolemia, and limb amputation. HYPOTHESIS The null hypothesis is that SGLT2 inhibitors do not reduce the incidence of CAV in transplanted patients. The alternative hypothesis is that SGLT2 inhibitors reduce the incidence of CAV in transplanted patients.METHODOLOGY Study Design A randomized clinical trial of superiority with active control (2 arms), with central randomization and blinded evaluation of outcomes, to evaluate the efficacy and safety of adding dapagliflozin or empagliflozin 10 mg once daily to conventional post-TxC treatment compared with the treatment of isolated conventional post-TxC for 6-8 months. Study Sample Sample: All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana. Inclusion Criteria Included: Patients of both sexes, aged ≥ 18 years, who have undergone heart transplantation between January 2017 and December 2023 and are under the care of the Heart Transplant and Heart Failure Unit at Hospital de Messejana.
The mechanism by which heart failure initiates and progresses and the mechanisms of heart repair remain unclear. The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity to recover. During surgery, the apical core tissue is routinely removed to allow the implantation of the device (this tissue is normally discarded). Some patients demonstrate cardiac recovery, allowing the device to be removed without later needing a transplant. As part of the LVAD removal procedure, the section around the device might need to be removed (this tissue is normally discarded). To further understand the cellular and molecular mechanisms by which the heart is repaired, the investigators wish to utilise this surplus tissue for research purposes. The collection of this tissue is part of routine treatment and does not represent additional risk for the patient for research purposes. Some patients might still require a transplant following VAD treatment. The native heart is removed from these patients (routinely discarded) and replaced by a donor heart. The investigators wish to utilise this discarded tissue for research purposes, so that the investigators can identify the cellular and molecular factors involved in cardiac repair and which distinguish responsive and non-responsive patients. Heart transplant recipients who require extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for research purposes when performed as part of routine clinical practice. There is no additional risk to the patient for research purposes. Heart failure patients scheduled for transplantation (who have not received a VAD) will be recruited prior to transplantation and their native heart retained for research purposes. An additional peripheral blood sample will be collected from all patients for research purposes when performed for routine clinical practice.
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device. EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD. The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric. EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency. The driving unit can be transported during operation.
Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels. Pediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population. Most exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).
The ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. This study aimed to reassess the prognostic significance of peak VO2 and to compare that with the Heart Failure Survival Score in the current optimized novel guideline-directed medical therapy (GDMT).
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.
1. Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing). 2. In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).
In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.
In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is a serious complication post-surgery, associated with worsened outcomes including mortality. However, predictors of decompensation after LVAD are not well established. Liver dysfunction pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS) is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis; cirrhosis). Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity and mortality in patients undergoing LVAD implantation and yields increased need for advanced postoperative HF therapies including the use of right ventricular assist devices (RVAD) for the management of RHF.