Cardiac Amyloidosis Registry of University Hospital Leipzig
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: Routine diagnostics, Routine treatment.
- Кому может быть актуально
- Состояния в реестре: Cardiac Amyloidosis. Базовые параметры: Без ограничений · 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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Обзор
This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.
Подробное описание
Cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. There is evidence from clinical trials about warning signs ("red flags"), diagnostic algorithms, and evidence for specific treatment. However, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. Furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities.
Clinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. Furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures.
The cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care University Hospital Leipzig. In particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.
Вмешательства
- Другое Routine diagnostics
Data collection of routine diagnostics - Другое Routine treatment
Data collection of routine treatment
Первичные конечные точки
- All-cause and cardiac mortality [Срок оценки: 10 years]
- Cumulative rate of patients with worsening heart failure [Срок оценки: 10 years]
- Rate of any hospitalizations [Срок оценки: 10 years]
- Change in left ventricular ejection fraction [Срок оценки: Every 6-12 months over 10 years]
- Change in left ventricular wall thickness [Срок оценки: Every 6-12 months over 10 years]
- Change in systolic arterial pressure [Срок оценки: Every 6-12 months over 10 years]
- Change in T1 values [Срок оценки: Approx. every 12 months over 10 years]
- Change in extracellular volume values [Срок оценки: Approx. every 12 months over 10 years]
- Change in N-Terminal Pro-B-Type Natriuretic Peptide over time [Срок оценки: Every 3-6 months over 10 years]
- Change in high-sensitivity cardiac troponin T over time [Срок оценки: Every 3-6 months over 10 years]
Вторичные конечные точки (7)
- Prevalence and incidence of cardiac and non-cardiac comorbidities [Срок оценки: Every 3-6 months over 10 years]
- New York Heart Association (NYHA) class over time [Срок оценки: Every 3-6 months over 10 years]
- Functional capacity over time [Срок оценки: Every 3-6 months over 10 years]
- Quality of life over time [Срок оценки: Every 3-6 months over 10 years]
- Vital signs over time [Срок оценки: Every 3-6 months over 10 years]
- Clinical signs of congestion over time [Срок оценки: Every 3-6 months over 10 years]
- Number of cardiovascular interventions [Срок оценки: Monitoring continuously over 10 years]
Критерии участия
Критерии включения
- Confirmed cardiac amyloidosis according to current standards
Критерии исключения
- refusal to participate
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- University Hospital Leipzig — Leipzig
Идентификаторы
NCT: NCT06129656 · UKL_CA_registry