{"id":899,"date":"2025-02-27T15:32:22","date_gmt":"2025-02-27T15:32:22","guid":{"rendered":"http:\/\/centogene.vl22350.dinaserver.com\/?page_id=899"},"modified":"2025-04-07T11:30:00","modified_gmt":"2025-04-07T11:30:00","slug":"analisis-epidemiologico-del-estudio-eha-sobre-la-enfermedad-de-angioedema-hereditario","status":"publish","type":"page","link":"https:\/\/www.centogene.com\/es\/pharma\/clinical-trial-support\/epidemiological-analysis-for-hereditary-angioedema-disease-eha-study\/","title":{"rendered":"Estudio EHA"},"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_EHA-header_55006e3c19.webp\" alt=\"csm_centogene-pharma-clinical-trails_EHA-header_55006e3c19\" \/>\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>Estudio EHA<\/h1>\r\n          <h2 class=\"bl-texto\">An\u00e1lisis epidemiol\u00f3gico de la enfermedad de angioedema hereditario<\/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<h3 class=\"wp-block-heading\">Descripci\u00f3n general<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">El an\u00e1lisis epidemiol\u00f3gico del angioedema hereditario (AHE) es un estudio observacional internacional. Su objetivo principal es investigar la prevalencia del angioedema hereditario (AEH) en participantes con episodios recurrentes de dolor abdominal sin etiolog\u00eda evidente. Adem\u00e1s, el estudio busca establecer biomarcadores de AEH que puedan facilitar un diagn\u00f3stico m\u00e1s temprano y la personalizaci\u00f3n del tratamiento en el futuro.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Beneficios para los participantes<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Los participantes pueden recibir un diagn\u00f3stico definitivo de AEH tipo 1\/2. Esto tambi\u00e9n puede tener un impacto directo en la familia de los sujetos diagnosticados debido a la herencia dominante de la enfermedad.<\/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\">El AEH es un trastorno hereditario autos\u00f3mico dominante que a menudo se diagnostica de forma insuficiente o err\u00f3nea. Los ataques recurrentes de dolor abdominal, que a veces son la \u00fanica manifestaci\u00f3n de la enfermedad, pueden confundirse con otras afecciones, como trastornos psiqui\u00e1tricos o apendicitis, lo que resulta en procedimientos m\u00e9dicos y quir\u00fargicos innecesarios.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La enfermedad no suele diagnosticarse hasta finales de la adolescencia, y las personas no diagnosticadas pueden sufrir episodios frecuentes de dolor abdominal que pueden afectar su calidad de vida. El estudio EHA contribuir\u00e1 al diagn\u00f3stico precoz de estas personas y, por lo tanto, a actualizar la prevalencia del AEH. Adem\u00e1s, los an\u00e1lisis bioqu\u00edmicos realizados en muestras positivas para AEH contribuir\u00e1n al desarrollo de nuevas herramientas diagn\u00f3sticas para el AEH.<\/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 participantes que cumplan los criterios de elegibilidad podr\u00e1n inscribirse en el estudio. A todos los participantes se les extraer\u00e1 una \u00fanica muestra de sangre (aproximadamente 1 ml). Esta 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 se enviar\u00e1 a CENTOGENE y se analizar\u00e1 en los laboratorios especializados de CENTOGENE para AEH. El proceso de diagn\u00f3stico consta de dos pasos: en el primero, se cuantifican las prote\u00ednas del complemento mediante espectrometr\u00eda de masas en t\u00e1ndem y, en el segundo, se confirman los resultados mediante an\u00e1lisis gen\u00e9ticos. Los resultados bioqu\u00edmicos se confirman gen\u00e9ticamente mediante secuenciaci\u00f3n de nueva generaci\u00f3n (NGS).&nbsp;<em>SERPING1<\/em>&nbsp;gen y, cuando es necesario, se realiza una amplificaci\u00f3n de sonda dependiente de ligadura multiplex (MLPA) para identificar grandes deleciones o duplicaciones.<br><br>CENTOGENE se pondr\u00e1 en contacto con el m\u00e9dico del estudio para informarle sobre los resultados de la prueba. Solo los participantes diagnosticados con AEH ser\u00e1n informados por su m\u00e9dico. Si el centro del estudio no se pone en contacto con el sujeto en el plazo de un mes, los resultados podr\u00e1n considerarse negativos.<\/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 observacional, multic\u00e9ntrico e internacional<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Poblaci\u00f3n de estudio:<\/strong>&nbsp;Personas con episodios previos de ataques de dolor abdominal sin etiolog\u00eda evidente<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>N\u00famero de participantes:&nbsp;<\/strong>5.000 participantes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Primer participante en:<\/strong>&nbsp;Septiembre de 2018<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00daltimo participante en:&nbsp;<\/strong>Junio de 2022<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Periodo de inclusi\u00f3n:<\/strong>&nbsp;48 meses<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Objetivos:<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Primario<\/strong>&nbsp;\u2013 Investigar la prevalencia de AEH en individuos con episodios previos de dolor abdominal sin etiolog\u00eda obvia<br><strong>Secundario<\/strong>&nbsp;\u2013 Establecer un biomarcador en la cohorte HAE-positiva<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><br>Descubre c\u00f3mo puedes participar:&nbsp;<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03558009?recrs=a&amp;type=Obsr&amp;cond=HAE&amp;rank=5\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov&nbsp;<\/a>&nbsp;|&nbsp;&nbsp;<strong>El reclutamiento est\u00e1 cerrado.<\/strong><\/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 o del padre\/tutor legal.<\/td><\/tr><tr><td>El participante ha experimentado episodios previos de dolor abdominal sin etiolog\u00eda obvia.<\/td><\/tr><tr><td>Participantes de entre 2 y 60 a\u00f1os<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u00c1mbito geogr\u00e1fico<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full imgshadow\"><img loading=\"lazy\" decoding=\"async\" width=\"1293\" height=\"701\" src=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/centogene_clinical_studies_global_patient_studies_200506-EHA-study-map.webp\" alt=\"\" class=\"wp-image-897\" srcset=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/centogene_clinical_studies_global_patient_studies_200506-EHA-study-map.webp 1293w, https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/centogene_clinical_studies_global_patient_studies_200506-EHA-study-map-1024x555.webp 1024w, https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/centogene_clinical_studies_global_patient_studies_200506-EHA-study-map-768x416.webp 768w\" sizes=\"auto, (max-width: 1293px) 100vw, 1293px\" \/><\/figure>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph\">Resumen de los pa\u00edses que participan en el estudio EHA. Los puntos indican la sede de CENTOGENE GmbH (Rostock, Alemania). (\u00a9 Colaboradores de OpenStreetMap)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El estudio EHA se est\u00e1 llevando a cabo en M\u00e9xico, Alemania, Italia, Turqu\u00eda, Polonia y Jap\u00f3n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Datos sobre la enfermedad de AEH<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Un trastorno hereditario caracterizado por angioedema mediado por bradicinina.<\/li>\n\n\n\n<li class=\"translation-block\">Enfermedad autos\u00f3mica dominante causada principalmente por mutaciones en el gen <em>SERPING1<\/em> , que codifica la prote\u00edna inhibidora de la esterasa C1 plasm\u00e1tica (C1-INH).<\/li>\n\n\n\n<li>La prevalencia publicada var\u00eda de 1:10.000 a 1:50.000.<\/li>\n\n\n\n<li>93% de los pacientes con HAE sufren dolor abdominal recurrente debido a edemas gastrointestinales, que podr\u00edan ser la \u00fanica manifestaci\u00f3n de la enfermedad.<\/li>\n\n\n\n<li>Las personas con s\u00edntomas gastrointestinales rara vez son sospechosas de tener AEH y pueden enfrentar un diagn\u00f3stico err\u00f3neo durante un promedio de ocho a\u00f1os.<\/li>\n<\/ul>\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%\">\n<p class=\"wp-block-paragraph\"><\/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\"   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\"> Estudio de contacto EHA<\/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. Anika Knaust, investigadora del estudio cl\u00ednico<\/strong><br \/>\nCENTOGENE GmbH<br \/>\nAm Strande 7<br \/>\n18055 Rostock<br \/>\nAlemania<br \/>\nCorreo electr\u00f3nico: Anika.Knaust@centogene.com<\/p>\n<hr \/>\n<p><strong>Limor Oren, asociada de investigaci\u00f3n cl\u00ednica<\/strong><br \/>\nCENTOGENE GmbH<br \/>\nAm Strande 7<br \/>\n18055 Rostock<br \/>\nAlemania<br \/>\nCorreo electr\u00f3nico: limor.oren@centogene.com<\/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\">Ensayos cl\u00ednicos<\/h5>\n<h4 class=\"translation-block\">Acceso al estudio en CentoPortal <sup>\u00ae<\/sup> 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  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