{"id":866,"date":"2025-02-27T14:52:43","date_gmt":"2025-02-27T14:52:43","guid":{"rendered":"http:\/\/centogene.vl22350.dinaserver.com\/?page_id=866"},"modified":"2025-12-23T10:41:55","modified_gmt":"2025-12-23T10:41:55","slug":"amiloidosis-hereditaria-relacionada-con-la-transtiretina-y-seguimiento-longitudinal-de-sujetos-positivos-para-ttr","status":"publish","type":"page","link":"https:\/\/www.centogene.com\/es\/pharma\/clinical-trial-support\/hereditary-transthyretin-related-amyloidosis-and-longitudinal-monitoring-of-ttr-positive-subjects-trammonittr\/","title":{"rendered":"TRAMmoniTTR"},"content":{"rendered":"<section class=\"bloque-banner-titulo-page  estilo-grey\" id=\"\">\r\n    \r\n    <div class=\"image-wrapper\">\r\n\r\n      <!-- include mp4 video on a loop -->\r\n              <img decoding=\"async\" class=\"\" src=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/csm_centogene-pharma-clinical-trails-tram-header_aef71fdfc5.webp\" alt=\"csm_centogene-pharma-clinical-trails-tram-header_aef71fdfc5\" \/>\r\n          <\/div>\r\n    <div class=\"container content-wrapper\">\r\n      <div class=\"row justify-content-start align-items-center\">\r\n\r\n\r\n        <div class=\"col-12 col-lg-6 animation fadeTop align-self-center\">\r\n                  <h1>TRAMmoniTTR<\/h1>\r\n          <h2 class=\"bl-texto\">Amiloidosis hereditaria relacionada con la transtiretina y seguimiento longitudinal de sujetos con TTR positivo<\/h2>                            <\/div>\r\n\r\n      <\/div>\r\n    <\/div>\r\n\r\n<\/section>\r\n<div class=\"breadcrumbs\">\r\n    <div class=\"container\">\r\n      <div class=\"row\">\r\n        <div class=\"col-12\">\r\n          <ul id=\"breadcrumbs\" class=\"breadcrumbs\"><li><a href=\"https:\/\/www.centogene.com\/es\/\">Inicio<\/a><\/li><\/ul>        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n<\/div>\r\n\r\n\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente-my\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\">Resumen<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">El estudio TRAMmoniTTR, que consiste en la detecci\u00f3n gen\u00e9tica de una poblaci\u00f3n de riesgo de amiloidosis hereditaria relacionada con la transtirretina y el seguimiento longitudinal de sujetos con TTR positivo, es un estudio longitudinal, epidemiol\u00f3gico, observacional y multic\u00e9ntrico.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Descripci\u00f3n general<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">El estudio TRAMmoni <em>TTR<\/em> tiene como objetivo investigar la prevalencia de ATTRv en una poblaci\u00f3n de riesgo, monitorizar el estado cl\u00ednico en sujetos positivos <em>para TTR<\/em> y establecer biomarcadores de ATTRv.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">La amiloidosis hereditaria por transtiretina es una enfermedad autos\u00f3mica dominante causada por una variante patog\u00e9nica en el gen <em>TTR<\/em> (Plante-Bordeneuve et al. 2011), tambi\u00e9n conocida como ATTRv (variante hereditaria de amiloidosis por transtiretina). El gen <em>TTR<\/em> codifica la prote\u00edna transtiretina (Ttr), anteriormente conocida como prealb\u00famina. La transtiretina se encuentra principalmente en el suero (secretada por el h\u00edgado) y el l\u00edquido cefalorraqu\u00eddeo (secretado por el plexo coroideo), y funciona como transportador de la hormona tiroxina (T4) y de la prote\u00edna de uni\u00f3n al retinol (unida al retinol o vitamina A). La desestabilizaci\u00f3n de la prote\u00edna Ttr y la formaci\u00f3n de prote\u00ednas Ttr mal plegadas dan lugar a las enfermedades de amiloidosis por transtiretina.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En promedio, el diagn\u00f3stico se retrasa entre 4 y 5 a\u00f1os, especialmente en zonas no end\u00e9micas. Adem\u00e1s, la heterogeneidad cl\u00ednica del ATTRv puede provocar diagn\u00f3sticos err\u00f3neos (Adams et al., 2016).<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">    <section class=\"bloque-personalizado bloque-cajas-imgs estilo-cajasblancas\" >\n        <div class=\"\"> \n                        <div class=\"row justify-content-between\">\n\n                                        \n                <div class=\"swiper-slide col-12 delay-1 caja\">\n                    <div class=\"caja-inner\" >\n                        <a href=\"https:\/\/www.centoportal.com\/\" target=\"_blank\" class=\"\">                        <div class=\"bl-imagen animationNo scalexTop delay-1\"><img decoding=\"async\" src=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/csm_centogene-pharma-clinical-trials_study-access-teaser-card_7fbd33e2a0-650x400.webp\" class=\"\" alt=\"\" \/> <\/div>                                               \n                        <\/a>                        \n                        <div class=\"caja-text\">\n                            <p class=\"prefijo\">Ensayos cl\u00ednicos<\/p>                            <h3 class=\"bl-titulo\">Acceso al estudio en CentoPortal\u00ae para los m\u00e9dicos participantes<\/h3>\n                                  \n                                                          <a target=\"_blank\" href=\"https:\/\/www.centoportal.com\/\" class=\"btn btn-primary\">CentoPortal\u00ae<\/a>\n                                                                          \n                        <\/div>                        \n                        \n                    <\/div>      \n                <\/div>       \n                \n                                     \n             \n            \n        <\/div>\n    <\/div>  \n<\/section>\n\n\n\n<\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    fondocolor\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<h2 class=\"wp-block-heading\">Fundamento y dise\u00f1o del estudio<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Fundamento del estudio<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">La amiloidosis hereditaria por transtiretina (ATTRv, amiloidosis hereditaria relacionada con la transtiretina) es una enfermedad autos\u00f3mica dominante causada por una variante patog\u00e9nica en el gen <em>TTR<\/em> (Plante-Bordeneuve et al. 2011). El gen <em>TTR<\/em> codifica la transtiretina, anteriormente conocida como prealb\u00famina. La transtiretina ( <em>TTR<\/em> ) se encuentra principalmente en el suero (secretada por el h\u00edgado) y el l\u00edquido cefalorraqu\u00eddeo (secretado por el plexo coroideo), y funciona como transportadora de la hormona tiroxina (T4) y de la prote\u00edna de uni\u00f3n al retinol (unida al retinol o a la vitamina A). La desestabilizaci\u00f3n de la prote\u00edna <em>TTR<\/em> y la formaci\u00f3n de prote\u00ednas Ttr mal plegadas dan lugar a la amiloidosis por transtiretina (ATTRv).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En promedio, el diagn\u00f3stico se retrasa entre 4 y 5 a\u00f1os, especialmente en zonas no end\u00e9micas. Adem\u00e1s, la heterogeneidad cl\u00ednica del ATTRv puede provocar diagn\u00f3sticos err\u00f3neos (Adams et al., 2016).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para facilitar el diagn\u00f3stico temprano, la elecci\u00f3n del tratamiento y la individualizaci\u00f3n, los biomarcadores ATTRv son cruciales.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Descubre c\u00f3mo puedes participar:\u00a0<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03237494\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Actualmente no hay opciones de tratamiento aprobadas por la FDA disponibles para pacientes con ATTRv.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Dise\u00f1o del estudio<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Los pacientes que cumplan los criterios de inclusi\u00f3n se inscribir\u00e1n en el estudio. A todos los participantes se les extraer\u00e1 una \u00fanica muestra de sangre para la investigaci\u00f3n, equivalente a 30 gotas de sangre (aproximadamente 1 ml). La muestra se aplicar\u00e1 a un&nbsp;<a href=\"https:\/\/www.centogene.com\/es\/innovacion\/centocard\/\" data-type=\"page\" data-id=\"1453\">CentoCard.<sup>\u00ae<\/sup><\/a>, que ser\u00e1 enviado a CENTOGENE y analizado en el laboratorio de CENTOGENE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">La muestra ser\u00e1 sometida a pruebas gen\u00e9ticas moleculares mediante secuenciaci\u00f3n basada en NGS del gen <em>TTR<\/em> completo.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>VISITAS TRIMESTRALES<\/th><th>TIEMPO<\/th><th>RECOLECCI\u00d3N DE SANGRE<\/th><th>eCRF<\/th><\/tr><\/thead><tbody><tr><td>Versi\u00f3n 1<\/td><td>0 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V2<\/td><td>3 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V3<\/td><td>6 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V4<\/td><td>9 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V5<\/td><td>12 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V6<\/td><td>15 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V7<\/td><td>18 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V8<\/td><td>21 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><tr><td>V9<\/td><td>24 meses<\/td><td>S\u00ed<\/td><td>S\u00ed<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">PUBLICACI\u00d3N DE LOS RESULTADOS DEL ESTUDIO TRAM: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/34658264\/\" target=\"_blank\" rel=\"noreferrer noopener\">ANALS DE MEDICINA; 53:1, 1787-1796. PUBLICADO EL 16 DE OCTUBRE DE 2021.<\/a><\/p>\n<\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente-my\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\">Informaci\u00f3n sobre el estudio<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Dise\u00f1o:<\/strong>&nbsp;Estudio epidemiol\u00f3gico, multic\u00e9ntrico, internacional y no intervencionista<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Poblaci\u00f3n de estudio:<\/strong>&nbsp;Participantes en riesgo de amiloidosis hereditaria por transtiretina (hATTR) y participantes diagnosticados con hATTR<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>N\u00famero de pacientes:&nbsp;<\/strong>5.000 participantes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Primer paciente en:<\/strong>&nbsp;Abril de 2018<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Fin del estudio:<\/strong>&nbsp;Abril de 2025<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Objetivos:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">Para monitorizar el estado cl\u00ednico en sujetos <em>con TTR<\/em> positiva<\/li>\n\n\n\n<li>Investigar la prevalencia de hATTR en una poblaci\u00f3n en riesgo<\/li>\n\n\n\n<li>Establecer biomarcadores hATTR<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Descubre c\u00f3mo puedes participar:&nbsp;<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03237494?term=tram2&amp;rank=1\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Criterios de inclusi\u00f3n<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Criterios de inclusi\u00f3n<\/th><\/tr><\/thead><tbody><tr><td>Se obtiene el consentimiento informado del participante.<\/td><\/tr><tr><td>El participante tiene 18 a\u00f1os o m\u00e1s.<\/td><\/tr><tr><td>El participante no tiene diagn\u00f3stico de alcoholismo seg\u00fan las pautas internacionales<\/td><\/tr><tr><td>El participante no ha recibido quimioterapia para ning\u00fan carcinoma.<\/td><\/tr><tr><td>El participante corre riesgo de presentar ATTRv debido a dos o m\u00e1s de los factores enumerados a continuaci\u00f3n:<ul class=\"wp-block-list\"><br><li>Miocardiopat\u00eda o polineuropat\u00eda sin etiolog\u00eda evidente<\/li><li>Polineuropat\u00eda desmielinizante inflamatoria cr\u00f3nica at\u00edpica (PDIC) o enfermedad de la neurona motora (EMN)<\/li><li>Disfunci\u00f3n auton\u00f3mica<\/li><li>Miocardiopat\u00eda hipertr\u00f3fica o insuficiencia card\u00edaca con fracci\u00f3n de eyecci\u00f3n conservada Hipertrofia ventricular izquierda (HVI)<\/li><li>S\u00edndrome del t\u00fanel carpiano bilateral<\/li><li>Estenosis espinal o radiculopat\u00eda espinal<\/li><li>Trastornos de la marcha<\/li><li>Cambios oculares que involucran opacidades v\u00edtreas<\/li><li>P\u00e9rdida de peso inexplicable &gt;5 kg<\/li><li>Anomal\u00edas renales<\/li><li class=\"translation-block\">Antecedentes familiares de ATTRv. Basado en im\u00e1genes o biopsia, sospecha de <em>TTR<\/em> de tipo salvaje (ATTR) y no sometido a pruebas gen\u00e9ticas para ATTRv.<\/li><\/ul>O<ul class=\"wp-block-list\"><li>Al participante se le diagnostica ATTRv<\/li><\/ul>O<ul class=\"wp-block-list\"><li class=\"translation-block\">El participante es un familiar de primer o segundo grado del sujeto positivo <em>para TTR.<\/em><\/li><br><\/ul><\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n  <section class=\"bloque-personalizado bloque-contact-info\" >     \n    <h2 class=\"mt-3 mb-5\"> Contacto con el estudio TRAMmoniTTR<\/h2>   \n    <div class=\"row justify-content-center bordesverticales\"> \n        <div class=\"bl-texto col-12 col-md-3\">\n         <h5 class=\"mt-0\">Para m\u00e1s informaci\u00f3n por favor contactar<\/h5>\n<p><strong>Dra. Filipa Curado, Gerente Senior de Proyectos Cl\u00ednicos<\/strong><br \/>\nDepartamento de Estudios Cl\u00ednicos<br \/>\nCENTOGENE GmbH<br \/>\nAm Strande 7<br \/>\n18055 Rostock<br \/>\nAlemania<br \/>\nCorreo electr\u00f3nico: <a title=\"Escribe un correo electr\u00f3nico\" href=\"mailto:filipa.curado@centogene.com\" data-mailto-vector=\"-4\">filipa.curado@centogene.com<\/a><\/p>\n        <\/div>\n        <div class=\"bl-texto  col-12 col-md-2\">\n          \n        <\/div>\n        <div class=\"bl-texto  col-12 col-md-3\">\n          <h5 class=\"mt-0\">Estudios cl\u00ednicos<\/h5>\n<h4>Acceso al estudio en CentoPortal para los m\u00e9dicos participantes<\/h4>\n<p><a class=\"btn btn-primary\" title=\"CentoPortal\" href=\"https:\/\/login.centoportal.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">CentoPortal<\/a><\/p>\n        <\/div>\n    <\/div>\n  <\/section>  \n\n  \n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":1078,"menu_order":30,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-866","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TRAMmoniTTR | CENTOGENE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.centogene.com\/es\/farmaceutica\/apoyo-a-ensayos-clinicos\/amiloidosis-hereditaria-relacionada-con-la-transtiretina-y-seguimiento-longitudinal-de-sujetos-positivos-para-ttr\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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