NCT03912181: ESTHYM

Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes

Completed Last updated 11 April 2019

What this trial tests

trial in Familial Chylomicronemia Syndrome in 140 participants. Completed in 1 February 2019.

Timeline

1 March 2018

Primary endpoint
1 December 2018

1 February 2019

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	140
Start date	1 March 2018
Primary completion	1 December 2018
Estimated completion	1 February 2019
Sites	1 location across France

Conditions studied

• Familial Chylomicronemia Syndrome — all drugs for Familial Chylomicronemia Syndrome →
• Multifactorial Chylomicronemia Syndrome — all drugs for Multifactorial Chylomicronemia Syndrome →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Familial Chylomicronemia Syndrome or Multifactorial Chylomicronemia Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).

A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.

This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 10-Year Comparative Follow-up of Familial versus Multifactorial Chylomicronemia Syndromes.
   Belhassen M, Van Ganse E, Nolin M, Bérard M, et al · · 2021 · cited 29× · PMID 33221907 · DOI 10.1210/clinem/dgaa838
2. Latent disease similarities and therapeutic repurposing possibilities uncovered by multi-modal generative topic modeling of human diseases.
   Kozawa S, Yokoyama H, Urayama K, Tejima K, et al · · 2023 · cited 1× · PMID 37123453 · DOI 10.1093/bioadv/vbad047