Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Detection of Cardiac Amyloidosis Using Right Ventricular Sensing Amplitude in Patients With Left Ventricular Hypertrophy (DETECT-AMY)

27 luglio 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

242

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Diagnostic Assessment During CIED Implantation
Single Group
Test diagnostico: 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)

Diagnostic Test: 99mTc-DPD or HMDP Scintigraphy Cardiac scintigraphy performed within 3 months after implantation to assess myocardial tracer uptake and detect cardiac amyloidosis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During CIED implantation
During CIED implantation
The prevalence of cardiac amyloidosis in the study population
Lasso di tempo: 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.
Lasso di tempo: 6 months after CIED implantation
6 months after CIED implantation
Change in RAND 36-Item Health Survey (SF-36) score
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Cattedra di studio: Philippe Le Corvoisier, MD, PhD, Assistance public Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2029

Completamento dello studio (Stimato)

5 maggio 2030

Date di iscrizione allo studio

Primo inviato

10 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2026

Primo Inserito (Effettivo)

29 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 luglio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP240915

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi