Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy

Официальное название

Diagnostic Performance of Right Ventricular Sensing Amplitude and Other Electrophysiological,Echographic, and Histological Parameters in Cardiac Amyloidosis Among Patients With Left Ventricular Hypertrophy: a Multicenter Prospective Study

Обзор

This multicenter prospective study aims to evaluate the diagnostic performance of right ventricular sensing amplitude measured during cardiac implantable electronic device (CIED) implantation (pacemaker or defibrillator) to identify cardiac amyloidosis in patients with left ventricular hypertrophy and conduction abnormalities. Patients aged 65 years or older referred for CIED implantation will be included. During the procedure, electrophysiological parameters will be recorded. Additional assessments will be performed, including cardiac scintigraphy, biological analyses, and subcutaneous adipose tissue biopsy. The results of these investigations will be used to confirm or rule out cardiac amyloidosis. Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC).

Вмешательства

• Диагностический тест Cardiac amyloidosis screening during CIED implantation
  Procedure of CIED implantation will not be modified by inclusion in the study. However, several exams will be performed to confirm or ruled out the diagnosis of cardiac amyloidosis: During the procedure: Subcutaneous adipose tissue sampling Collection of a subcutaneous adipose tissue sample during device implantation for histological analysis to detect amyloid deposits. Blood sampling for serum free light chain assay, serum and urine electrophoresis with immunofixation (baseline visit) Diagno

Первичные конечные точки

• Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis [Срок оценки: During CIED implantation]

Вторичные конечные точки (11)

• Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis [Срок оценки: During hospitalization for CEID implantation (Day 0)]
• Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis [Срок оценки: During hospitalization for CEID implantation (Day 0)]
• Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis [Срок оценки: During hospitalization for CEID implantation (Day 0)]
• Diagnostic performance of maximal end-diastolic interventricular septal thickness [Срок оценки: During hospitalization for CEID implantation (Day 0)]
• Diagnostic performance of adipose tissue histology [Срок оценки: During hospitalization for CEID implantation (Day-0)]
• Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds [Срок оценки: 6 months after CIED implantation (Day 0)]
• The implantation procedure duration (min) between patients with or without cardiac amyloidosis [Срок оценки: During CIED implantation]
• The prevalence of cardiac amyloidosis in the study population [Срок оценки: Up to 3 months after CIED implantation]
• The proportion of modifications in the treatment at the 6-month visit. [Срок оценки: 6 months after CIED implantation]
• Change in RAND 36-Item Health Survey (SF-36) score [Срок оценки: Inclusion and 6 months after CIED implantation]
• Change in New York Heart Association (NYHA) Functional Classification [Срок оценки: Inclusion and 6 months after CIED implantation]

Критерии участия

Критерии включения

• Patient referred for CIED implantation (pacemaker or Implantable Cardioverter Defibrillator with a pacemaker feature) due to at least one conduction abnormality (Atrioventricular block, Sinoatrial block or Atrial fibrillation with slow ventricular rate). Patients referred for implantation of an Implantable Cardioverter Defibrillator with a pacemaker feature can be included if they present one of these conduction abnormalities.
• Left ventricular hypertrophy definite as maximal end-diastolic interventricular septum thickness ≥ 12mm
• Patients aged ≥ 65 years
• Written consent
• Patient affiliated to a social security

Критерии исключения

• Severe aortic stenosis (valve area ≤ 1 cm2)
• Known cardiac amyloidosis
• Indication for cardiac resynchronisation therapy
• Indication for left bundle branch physiological pacing
• Ejection fraction < 45% on echocardiography.
• Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.
• Patient on AME (state medical aid)
• Adults subject to a legal protection measure (guardianship, curatorship, or safeguard of justice).
• Patients deprived of their liberty by a judicial or administrative decision.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07734285 · APHP240915

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗