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Набор скоро начнётся NCT06794710

Early Identification and Treatment of Rare Cardiomyopathy Cohorts

Без фазы С лечением Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Metabolic Cardiomyopathy Restrictive 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
В протоколе указаны: diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids, Close follow-up, early rehabilitation guidance.
Кому может быть актуально
Состояния в реестре: Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Metabolic Cardiomyopathy, Restrictive Cardiomyopathy. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
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Официальное название

Early Identification and Treatment of Rare Myocardium by Multimodal Imaging (EARLY-MYO-RARE)

Обзор

This study aims to further develop an imaging-guided cohort of rare cardiomyopathies based on the existing database. The investigators will standardize the construction of a cohort that integrates a clinical data repository, serum biobank, myocardial tissue bank, and imaging database. In the current cohort, the investigators will systematically screen for biomarkers indicative of pathological changes in challenging cardiomyopathies. Multidimensional data will be integrated to establish and optimize a heart failure risk assessment model, which will then be validated in a prospective cohort. The effectiveness of the model in assessing different risk groups will be evaluated, with the goal of achieving precise prevention of heart failure from the source.

Подробное описание

To answer what are the key clinical questions of patients with rare cardiomyopathies resulted in high risk of adverse outcomes and requiring intensified treatment, this study will systematically refine and expand the cohort. This study will combine multimodal imaging with clinical data, blood samples, myocardial tissue samples to retrospectively identify biomarkers associated with pathological changes in rare cardiomyopathies; thereby to integrate multi-dimensional data to develop and validate a prognostic risk assessment model and evaluate the effectiveness of treatments guided through prospective randomized controlled trials by this model. Ultimately, this study aims to offer an integrated solution for the diagnosis and treatment of rare cardiomyopathies.

Вмешательства

  • Препарат diuretics, ACEIs/ARBs, beta blockers, positive inotropic drugs, MRAs, SGLT2i, retinoids
    Patients in this group will receive pharmacological treatment for heart failure.
  • Поведенческое Close follow-up
    High risk patients receive close follow-up
  • Поведенческое early rehabilitation guidance
    Early rehabilitation guidance such as cardiopulmonary exercise tests and cardiac rehabilitation therapy

Первичные конечные точки

  • The Heart Failure Incidence of Rare cardiomyopathy [Срок оценки: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
Вторичные конечные точки (4)
  • Assessment of Changes in Cardiac Morphological Characteristics [Срок оценки: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
  • Quantitative Assessment of Changes in Cardiac Tissue Characteristics [Срок оценки: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
  • NT-proBNP [Срок оценки: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]
  • VO2max [Срок оценки: From the date of recruitment, heart failure will be assessed within 24 hours, followed by assessments every six months during the follow-up period, up to 24 months.]

Критерии участия

Критерии включения

  • Age 18-75 years old.
  • Patients preliminarily diagnosed with heart failure and scheduled to receive drug therapy after being evaluated by cardiology departments.
  • No history of structural heart disease, and the Framingham score \<5 (for patients with the Framingham score ≥5, coronary artery disease will be excluded by coronary angiography/coronary CT/exercise platelet).
  • Creatinine clearance ≥50ml/min (Cockcroft-Gault formula).
  • LVEF ≥50% assessed by Echocardiography.
  • QT interval \< 470 ms.
  • Providing written informed consent.

Критерии исключения

  • Presence of acute/chronic renal impairment (GFR \<50/ml/min/1.73m2).
  • History of cardiovascular disease such as confirmed coronary artery disease, valvular disease, cardiomyopathy, congenital heart disease, and heart failure.
  • Presence of contraindications to CMR.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06794710 · RARE2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗