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

27 juli 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

242

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Diagnostic Assessment During CIED Implantation
Single Group
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: During CIED implantation
During CIED implantation
The prevalence of cardiac amyloidosis in the study population
Tijdsspanne: 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.
Tijdsspanne: 6 months after CIED implantation
6 months after CIED implantation
Change in RAND 36-Item Health Survey (SF-36) score
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Onderzoekers

  • Studie stoel: Philippe Le Corvoisier, MD, PhD, Assistance public Hôpitaux de Paris

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

5 mei 2030

Studieregistratiedata

Eerst ingediend

10 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

29 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

27 juli 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APHP240915

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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