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Search / Trial NCT06101108

Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery

Launched by PHILIPPE DEBONNAIRE · Oct 20, 2023

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how to identify a heart condition called transthyretin amyloid cardiomyopathy (ATTR) in older patients who are having surgery for narrowing of the spinal canal, which can cause back pain and other symptoms. During the surgery, doctors found unusual protein deposits in the tissue that was removed, and these deposits might indicate that the heart could also be affected by this condition. The goal of the study is to keep track of these patients over their lifetime to see how their heart health develops after surgery.

To be eligible for this study, participants must be 60 years or older and have been diagnosed with lumbar spinal canal stenosis, which is a narrowing of the space in the lower back that can lead to pain and mobility issues. They also need to have specific findings from a tissue sample taken during surgery. Participants will have regular follow-ups with a cardiologist, where doctors will collect information about their health and perform necessary tests like blood tests and heart scans. It’s important to note that these tests are standard care and would be done whether or not patients join the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ≥ 60 years old
  • Lumbar spinal canal stenosis, undergoing spinal surgery
  • Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
  • Exclusion Criteria:
  • Prior diagnosis of cardiac amyloidosis
  • Unwilling to provide informed consent

About Philippe Debonnaire

Philippe Debonnaire is a distinguished clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With extensive experience in the pharmaceutical and biotechnology industries, Debonnaire spearheads innovative clinical studies that prioritize safety, efficacy, and ethical standards. His leadership emphasizes collaboration with healthcare professionals, regulatory bodies, and patient communities to ensure that trials are conducted with integrity and transparency. Driven by a passion for scientific discovery, Philippe Debonnaire aims to contribute significantly to the development of groundbreaking therapies that address unmet medical needs.

Locations

Brugge, Belgium

Patients applied

0 patients applied

Trial Officials

Philippe Debonnaire, MD, PhD

Principal Investigator

AZ Sint-Jan Brugge AV

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported