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NCT03373279
Patients with marginal physiologic reserve, severe frailty, and/or malnutrition may be regarded as unsuitable candidates for advanced cardiac replacement therapies. However, little data exist on precisely which measures are predictive of subsequent adverse events. Assessment of nutritional status and frailty is still largely predicated on crude and obsolete parameters, such as baseline serum albumin level or body mass index (BMI). In this prospective cohort study the investigators will evaluate the use of bio-electrical impedance spectroscopy (BIS) as a measure of body composition and assess the associations with surgical outcomes.
NCT06428097
This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
NCT03102125
The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.
NCT06453148
Prospective cohort clinical study, registry-based, multicenter, national, with the consecutive inclusion of patients with a history of Heart Transplantation in Brazil. The clinical registry will involve the participation until 25 centers. Patients will be included up to 30 days after Heart Transplant surgery and will be followed for one year. Laboratory tests and clinical parameters wil be collected in two clinical visits (6mo and 12 mo). The outcomes evaluate will be the total hospitalizations and all-cause death. It is expected to include 730 patients with a 12-month follow-up from the day of the transplant surgery. The findings of the HESTIA Registry may guide the management of post-heart transplant patients, aiming at reducing morbidity and mortality within 12 months after heart transplant surgery.
NCT06338306
Heart transplant is the only effective treatment for people with advanced heart failure. Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors. To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant. Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes. Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent. The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them. This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors. The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC". The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC). The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy.
NCT03386539
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).
NCT03499197
The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.