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Heart Transplantation clinical trials

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NCT ID: NCT03991923 Active, not recruiting - Clinical trials for Heart Transplantation

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Start date: November 25, 2020
Phase: N/A
Study type: Interventional

The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

NCT ID: NCT03809676 Completed - Clinical trials for Periodontal Diseases

Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls

Start date: January 9, 2018
Phase:
Study type: Observational

Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.

NCT ID: NCT03687723 Recruiting - Clinical trials for Heart Transplantation

Observational Study of the Clinical Use of the OCS™ Heart

Start date: October 2016
Phase:
Study type: Observational

Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)

NCT ID: NCT03292861 Enrolling by invitation - Clinical trials for Heart Transplantation

The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients

Start date: September 13, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, controlled, single center study to evaluate the efficacy of Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and steroids in the prevention of CAV. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours. Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21 to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed. All patients will be followed and monitored according to standard of care protocols for heart transplant recipients at our center.

NCT ID: NCT03234205 Completed - Clinical trials for Heart Transplantation

Measurements of Myocardial Relaxation Time by MRI During Respiration

ARTEMIS
Start date: August 31, 2011
Phase: N/A
Study type: Interventional

Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable. This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts. The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients. The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.

NCT ID: NCT03152422 Active, not recruiting - Clinical trials for Heart Transplantation

Urinary Proteomics in Predicting Heart Transplantation Outcomes

uPROPHET
Start date: October 1, 2016
Phase:
Study type: Observational

uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft performance is recipients of heart transplants

NCT ID: NCT03105726 Completed - Heart Failure Clinical Trials

Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)

MEVADE
Start date: November 2010
Phase: N/A
Study type: Observational

End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.

NCT ID: NCT03026634 Completed - Heart Failure Clinical Trials

Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation

HTx-HDZ-SDB-1
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.

NCT ID: NCT02938676 Not yet recruiting - Clinical trials for Heart Transplantation

Satisfaction Degree in a Nurse Educational Program to Heart Transplant Patient

Start date: November 2016
Phase: N/A
Study type: Observational

Any member of the research team conducted screening for the selection of eligible patients. Nurses will be responsible for delivering the "Guide tips for the person with a transplanted heart", thus initiating an individualized education program. Education will be held at the time of admission in which the patient has passed the most critical post-operative. Educational tips guide contains all the information necessary for the patient to have a first contact on the habits that must change. Education lasts 10-30 minutes and is taught in daytime, in a calm environment and at the right time, favoring the presence of the caregiver. Later, education is reinforced on the doubts that arise both the patient and the primary caregiver. During the first days of admission to the unit of cardiology, socio-demographic data of the patient and primary caregiver by the research team will be collected. A few days before discharge, having left time between 7-8 days after delivery of educational advice guide, any member of the research team, who does not work in the cardiology unit, will provide the patient and the primary caregiver the satisfaction questionnaire where the perception of information and education received during the postoperative period in the inpatient cardiology unit and the appropriateness of the topics covered in the guide educational advice.

NCT ID: NCT02864706 Completed - Clinical trials for Heart Transplantation

SCHEDULE Follow Up Visit 5-7 yr

CRAD001ANO05
Start date: January 18, 2016
Phase: Phase 4
Study type: Interventional

The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.