The REMATCH trial: rationale, design, and end points
| Autor: | Daniel F. Heitjan, Daniel J. Goldstein, John T. Watson, Alan J. Moskowitz, Milton Packer, Eric A. Rose, Peter A. Shapiro, Deborah D. Ascheim, Anita R. Tierney, Lynne Warner Stevenson, Alan D. Weinberg, Paul Meier, Deborah L. Williams, Annetine C. Gelijns, Josephine A. Sollano, Ronald M. Lazar, Ronald G Levitan |
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| Rok vydání: | 1999 |
| Předmět: |
Pulmonary and Respiratory Medicine
Heart transplantation Research design medicine.medical_specialty Heart disease business.industry medicine.medical_treatment MEDLINE medicine.disease law.invention Clinical trial Transplantation law Heart failure Artificial heart medicine Surgery Cardiology and Cardiovascular Medicine Intensive care medicine business |
| Zdroj: | The Annals of Thoracic Surgery. 67:723-730 |
| ISSN: | 0003-4975 |
| Popis: | Background. Because left ventricular assist devices have recently been approved by the Food and Drug Administration to support the circulation of patients with end-stage heart failure awaiting cardiac transplantation, these devices are increasingly being considered as a potential alternative to biologic cardiac replacement. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial is a multicenter study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation. Methods. We discuss the rationale for conducting REMATCH, the obstacles to designing this and other randomized surgical trials, the lessons learned in conducting the multicenter pilot study, and the features of the REMATCH study design (objectives, target population, treatments, end points, analysis, and trial organization). Conclusions. We consider what will be learned from REMATCH, expectations for expanding the use of left ventricular assist devices, and future directions for assessing clinical procedures. |
| Databáze: | OpenAIRE |
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