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OBJECTIVES: The primary objective of this master thesis in clinical research is to evaluate the proportion of patients who are eligible for the sympathetic renal denervation, the power of the criteria for eligibility and the causes of exclusion in the pilot phase of the academic randomized trial INSPiRED. BACKGROUND: The efficacy and the security of the renal denervation by catheterization in the treatment of resistant hypertension are controversial. The randomized Belgian prospective study of phase 2 INSPiRED has been launched in 2014 in order to respond to the criticisms made of previous trials. New criteria of eligibility and exclusion were submitted in order to better target the population of patients with hypertension that could benefit from this approach. According to the results of the pilot phase, on the way to completion, the scope of the study could be extended to the European web ENCORED.METHODS: In the pilot phase of the trial INSPiRED, the resistant hypertension patients were randomly assigned in a 1:1 ratio in the denervation group or contra! (Maximized medical treatment). Twenty-three patients were equally referred to the center of the Cliniques Universitaires Saint-Luc and the Grand Hospital de Charleroi. We will compare our results to the other randomized studies - some double-blinded - carried out between 2010 and 2015.RESULTS Out of the 23 analyzed patients, 18 patients (78%) were eligible and 5 were immediately excluded. However, 7 out of the 18 eligible patients were lost to follow-up (38%), despite our energetic efforts to get back in touch with them. Only 11 patients were randomized (48%), 6 in the denervation group and 5 in the contra! group. Ultimately, 12 patients (52%) were excluded. The exclusions were due to patients lost to follow-up (64%), normalized blood pressure at the screening (27%), the discovery of fibromuscular dysplasia during the renal angiography (15%), and the withdrawal consent (9%).CONCLUSION In our pilot phase, the proportion of eligible patients is higher than in the other studies. The refractory phenotype of the resistant hypertension and the use of severest criteria for the eligibility and the exclusion may partially explain our results.The legitimacy of those criteria will be shown after the analysis of the results of the study, in terms of efficacy and security. After the exclusion of vascular patients and/or very old patients, white coat hypertensions and/or secondary hypertensions, we are still left with a group of patients who are less reliable, difficult to follow and probably less compliant to treatment. Renal denervation might be efficacy, even radical but costly for some patients. Otherwise, evaluate the psychological statement of those patients to describe the care, including psychological aspects which are supposed to perform the response and the compliance to treatment. OBJECTIFS : Ce mémoire a pour objectif principal d'évaluer la proportion de patients éligibles pour la dénervation sympathique rénale, la pertinence des critères d'éligibilité et les causes d'exclusion dans la phase pilote de l'essai randomisé académique INSPiRED.CONTEXTE L'efficacité et la sécurité de la dénervation rénale par voie endovasculaire dans le traitement de l'hypertension artérielle résistante restent controversés. L'étude belge prospective randomisée de phase 2 INSPiRED a été initiée en 2014 pour répondre aux critiques soulevées par les essais précédents. De nouveaux critères d'éligibilité et d'exclusion ont été proposés afin de mieux cibler la population d'hypertendus susceptibles de bénéficier de cette approche. En fonction des résultats de la phase pilote, en voie d'achèvement, l'étude pourrait être élargie à l'ensemble du réseau européen ENCORED.METHODE Dans la phase pilote de l'étude INSPiRED, les patients hypertendus résistants ont été randomisés (1: 1) dans le groupe dénervé versus contrôle (traitement médicamenteux optimal). Vingt-trois patients ont été référés, également sur le site des Cliniques Universitaires Saint-Luc et du Grand Hôpital de Charleroi. Nous comparons nos résultats à ceux des études randomisées, certaines en double aveugle, menées de 2010 à 2015.RESULTATS Parmi les 23 patients analysés, 18 patients (78%) se sont avérés éligibles et 5 ont été exclus d'emblée. Néanmoins, 7 des 18 patients éligibles ont été perdus de vue (38%), malgré des efforts énergiques pour les recontacter. Dès lors, seuls 11 patients ont été randomisés (48%), 6 dans le groupe dénervation rénale et 5 dans le groupe contrôle. In fine, 12 patients ont été exclus. Les exclusions sont imputables aux perdus de vue (64%), à la normalisation de la pression artérielle lors du screening (27%), à la découverte d'une dysplasie fibromusculaire à l'angiographie des artères rénales (15%) et au retrait du consentement (9%)CONCLUSION Dans notre phase pilote, la proportion de patients éligibles pour la dénervation rénale est supérieure aux autres études. Ces résultats s'expliquent en partie par le phénotype réfractaire des hypertensions artérielles résistantes et l'utilisation de critères d'éligibilité et d'exclusion plus stricts. La légitimité de ces critères ne sera démontrée qu'après analyse des résultats de l'étude, en termes d'efficacité et de sécurité. Après avoir exclu les patients vasculaires et/ou très âgés, les hypertensions artérielles résistantes « blouse blanche » et/ou les hypertensions artérielles secondaires, nous nous retrouvons avec un groupe de patients peu fiables, difficiles à suivre et probablement médiocrement adhérents au traitement. La dénervation rénale pourrait s'avérer une solution efficace, voire radicale mais coûteuses pour certains d'entre eux. Une autre voie consiste à étudier le profil psychologique de ces patients, afin de définir une prise en charge intégrant les aspects psychologiques susceptibles d'améliorer la réponse et l'adhésion au traitement.

Sympathectomy --- Randomized Controlled Trials as Topic --- Kidney

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Breast --- Breast Neoplasms --- Randomized Controlled Trials. --- Cancer --- Treatment. --- therapy.

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WG 580 Aneurysms --- Academic Dissertations --- Aneurysm --- Netherlands --- Randomized Controlled Trials

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"This book is a pivotal textbook for those considering, undertaking or appraising an evidence synthesis based on IPD for clinical research, especially those interested in intervention effects, modifiers of treatment response, identification of risk or prognostic factors, and the development and validation of risk prediction models. It covers all the key concepts and stages of a systematic review and meta-analysis of IPD, focusing primarily on the synthesis of randomised trials, as well as specialist topics, such as risk prediction, observational studies and advanced statistical methods. The book offers non-technical and practical examples, summary and learning points, and guidance including reporting criteria, software demonstrations, and illustrated applications. Describing the key features of the approach, this book will enable the reader to: Understand when the IPD approach is needed. How to undertake the systematic review and identify relevant evidence. How to obtain, check and manage the IPD How to minimise potential biases and clearly report methods and results. How to make the best use of IPD meta-analyses to inform policy, practice and research. Case-study chapters are also provided, where the trials and tribulations of undertaking IPD projects of randomised trials and observational studies are described by researchers in a range of clinical fields"--

Meta-Analysis as Topic --- Data Interpretation, Statistical --- Models, Statistical --- Randomized Controlled Trials as Topic --- Data Interpretation, Statistical. --- Meta-Analysis as Topic. --- Models, Statistical. --- Randomized Controlled Trials as Topic.

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Randomized Controlled Trials as Topic. --- Probability Theory. --- Clinical trials --- Sampling (Statistics) --- Etudes cliniques --- Echantillonnage (Statistique)