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Идёт набор NCT04776824

Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)

— Наблюдательное Amyloid 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: Amyloid Cardiomyopathy. Базовые параметры: от 18 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Cardiac transthyretin amyloidosis (ATTR), caused by ventricular depositions of misfolded transthyretin, results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, diastolic and systolic dysfunction to the development of terminal heart failure. Recently, treatment options for TTR amyloidosis have become available. However costs for therapy are enormous and previous trials were not able to differentiate between patients that might benefit from treatment and those without a need for treatment. the investigators study aims to determine markers, as assessed by cardiac magnet resonance imaging (CMR) feature tracking (FT) and T1- and T2- mapping, that might reliably indicate disease severity and could help to identify patients that might benefit from (ongoing) TTR stabilization treatment.

Подробное описание

Cardiac transthyretin amyloidosis (ATTR), the most common amyloidosis form with cardiac involvement, is caused by tissue deposition of misfolded TTR, a transport Protein for thyroxine and retinol. Ventricular depositions of amyloid fibrils results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, to diastolic and systolic dysfunction and finally chronic heart failure.

While treatment options are now available, it remains unclear how to monitor therapy response and disease progression. No makers have been identified that predict outcome prior to initiation of therapy, thus patient selection for therapy remains challenging.

The investigators study will address these issues and will provide systematically assessed CMR data before and over the course of 18 months after therapy initiation. Clinical and laboratory follow-up will be performed every 3-6 months. The investigators study is based on an open, uncontrolled, structured collection of retrospective and prospective data from all patients diagnosed with amyloidosis at the Inselspital Bern with the aim to follow patients undergoing therapy.

The investigators hypothesize that CMR feature tracking (FT) and measures of T1- and T2- mapping, such as extracellular volume (ECV) may better correlate with disease severity and help to identify patients likely to benefit from (ongoing) TTR stabilizing therapy. Beside standard CMR assessments, the investigators will use CMR feature tracking to quantify global and regional myocardial function. FT has proven to be an excellent predictor in various cardiomyopathies.

The proposed study will evaluate the potential of CMR to identify patients likely to benefit from therapy, monitor treatment response and balance individual patient benefit and health care cost.

Первичные конечные точки

  • LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac event) [Срок оценки: 5 years]
  • LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE [Срок оценки: 5 years]
  • Late gadolinium enhancement as predictor for MACE [Срок оценки: 5 years]
  • Extracellular volume (ECV) as predictor for MACE [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Confirmed diagnosis of amyloidosis w/wo cardiac involvement
  • General Consent

Критерии исключения

  • Inability to give consent or existence of a written or documented oral refusal of the data subject.<18 years of age

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Швейцария · 7 центров
  • USB — Basel
  • Department of Cardiology, University Hospital Bern, Inselspital, Bern — Bern
  • HUG — Geneva
  • CHUV — Lausanne
  • LUKS — Lucerne
  • KSSG — Sankt Gallen
  • Stadtspital Triemli — Zurich

Публикации

  • Dobner S, Tawo S, Noti F, Wieser F, Grani C, Nitsche C, Reichlin T, Hunziker L, Haeberlin A. Indication and electrical performance of conventional, resynchronization, and conduction system pacing in transthyretin amyloid cardiomyopathy. Heart Rhythm O2. 2026 Mar 27;7(7):1289-1301. doi: 10.1016/j.hroo.2026.03.026. eCollection 2026 Jul. PMID 42488169
  • Caobelli F, Popescu CE, Gozlugol N, Rominger A, Zangeneh FA, Munsch LH, Ciocca N, Stortecky S, Dobner S, Hundertmark M, Grani C. Correlation of global and regional quantitative 99m Tc-3,3-diphosphono-1,2 propanodicarboxylicacid single-photon emission computed tomography with echocardiography in patients with suspected transthyretin-related cardiomyopathy. Nucl Med Commun. 2026 Jun 1;47(6):638-643. PMID 41804669
  • Caobelli F, Gozlugol N, Bakula A, Rominger A, Schepers R, Stortecky S, Hunziker Munsch L, Dobner S, Grani C. Prognostic Value of [99mTc]Tc-DPD Quantitative SPECT/CT in Patients with Suspected and Confirmed Amyloid Transthyretin-Related Cardiomyopathy and Preserved Left Ventricular Function. J Nucl Med. 2024 Jun 3;65(6):944-951. doi: 10.2967/jnumed.123.266926. PMID 38724281

Идентификаторы

NCT: NCT04776824 · 2021-00135

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗