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Идёт набор NCT04265040

DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies

— Наблюдательное Non-ischemic Cardiomyopathy DCM - Dilated Cardiomyopathy HCM - Hypertrophic Cardiomyopathy HOCM - Hypertrophic Obstructive Cardiomyopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy, HOCM - Hypertrophic Obstructive Cardiomyopathy. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)

Обзор

The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity. This DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. "Clinical phenotyping, follow-up \& biosampling" 2. "Genomics", 3. "Inflammation" and 4. "Biomarker". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.

Первичные конечные точки

  • all-cause mortality [Срок оценки: 4 years]

Критерии участия

Критерии включения

  • Non-ischemic structural cardiomyopathies
  • Age ≥ 18 or ≤ 80 years
  • The patient is able to understand the declaration of consent and to sign it dated
  • At least one of the following diagnoses depending on the specific TORCH-

Plus inclusion / exclusion - SOP:

Dilated Cardiomyopathy (DCM)

  • family / genetic
  • inflammatory / persistent myocarditis
  • idiopathic (after exclusion secondary cause)
  • left sided systolic dysfunction (EF ≤ 45%)

Left ventricular hypertrophy

  • sarcomere hypertrophic cardiomoypathia (HCM, HOCM)
  • amyloid (AL: light chains, TTR: transthyretin, wild type)

Left ventricular non-compaction cardiomyopathy (LVNC)

Arrhythmogenic right ventricular cardiomyopathy (ARVC / D)

Критерии исключения

The following exclusion criteria have been defined and must be taken from the TORCH-Plus specific inclusion / exclusion - SOP in detail:

  • Age: <18 years or> 80 years
  • Patient has other (cardiac) previous illnesses:
  • uncontrollable arterial hypertension
  • primary pulmonary arterial hypertension
  • radiation therapy in the chest area
  • addiction (drug or alcohol abuse)
  • life expectancy <1 year due to non-cardiological pre-existing conditions
  • significant heart valve disease
  • ischemic diseases and severe congenital heart diseases (including VSD, Fallot tetralogy, Ebstein anomaly)
  • chemotoxic cardiomyopathy
  • condition after myocarditis
  • combination of several traditional risk factors (e.g. hypertension and diabetes mellitus)
  • advanced chronic non-cardiac disease (e.g. chronic hepatitis or HIV)
  • Tachymyopathy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Германия · 1 центр
  • University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology — Heidelberg

Идентификаторы

NCT: NCT04265040 · TORCH-Plus DZHK21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗