Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy (DETECT-AMY)
2026年7月27日 更新者：Assistance Publique - Hôpitaux de Paris
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
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).
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
242
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Samia BALOUL
- 電話番号：0149 81 33 85
- メール：samia.baloul@aphp.fr
研究連絡先のバックアップ
- 名前：Philippe Le Corvoisier, MD, PhD
- 電話番号：01 49 81 37 96
- メール：philippe.lecorvoisier@aphp.fr
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Diagnostic Assessment During CIED Implantation
Single Group
|
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) Diagnostic Test: 99mTc-DPD or HMDP Scintigraphy Cardiac scintigraphy performed within 3 months after implantation to assess myocardial tracer uptake and detect cardiac amyloidosis. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
時間枠：During CIED implantation
|
The area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude, measured during CIED implantation in patients with conduction abnormalities, for the identification of patients with cardiac amyloidosis.
|
During CIED implantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
時間枠：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis
時間枠：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis
時間枠：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of maximal end-diastolic interventricular septal thickness
時間枠：During hospitalization for CEID implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of maximal end-diastolic interventricular septum thickness at echocardiography for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day 0)
|
|
Diagnostic performance of adipose tissue histology
時間枠：During hospitalization for CEID implantation (Day-0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of histological analysis of adipose tissue for identifying patients with cardiac amyloidosis.
|
During hospitalization for CEID implantation (Day-0)
|
|
Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds
時間枠：6 months after CIED implantation (Day 0)
|
The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of 12-lead electrocardiogram data (low voltage in limb leads) for identifying patients with cardiac amyloidosis.
|
6 months after CIED implantation (Day 0)
|
|
The implantation procedure duration (min) between patients with or without cardiac amyloidosis
時間枠：During CIED implantation
|
During CIED implantation
|
|
|
The prevalence of cardiac amyloidosis in the study population
時間枠：Up to 3 months after CIED implantation
|
Up to 3 months after CIED implantation
|
|
|
The proportion of modifications in the treatment at the 6-month visit.
時間枠：6 months after CIED implantation
|
6 months after CIED implantation
|
|
|
Change in RAND 36-Item Health Survey (SF-36) score
時間枠：Inclusion and 6 months after CIED implantation
|
Change in health-related quality of life between inclusion and the 6-month visit, assessed using the RAND 36-Item Health Survey, Version 1.0 (SF-36).
The questionnaire comprises 36 items grouped into 8 domains.
Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
|
Inclusion and 6 months after CIED implantation
|
|
Change in New York Heart Association (NYHA) Functional Classification
時間枠：Inclusion and 6 months after CIED implantation
|
Change in New York Heart Association (NYHA) Functional Classification between baseline and the 6-month visit in patients with and without cardiac amyloidosis.
The NYHA Functional Classification ranges from Class I to Class IV, with higher class indicating worse functional status.
|
Inclusion and 6 months after CIED implantation
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Philippe Le Corvoisier, MD, PhD、Assistance public Hôpitaux de Paris
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2030年5月5日
試験登録日
最初に提出
2026年7月10日
QC基準を満たした最初の提出物
2026年7月27日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月29日
QC基準を満たした最後の更新が送信されました
2026年7月27日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- APHP240915
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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