A Prospective, Single-center, Open-label Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves. (PROMETA)

Ascending aortic aneurysms (AAAs) are serious conditions that can lead to aortic dissections or ruptures, carrying a high risk of mortality. Their pathophysiology is based on complex mechanisms involving inflammatory and metabolic processes, as well as alterations in mitochondrial function. The presence of a bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) significantly influences the progression and severity of aneurysms. Bicuspid aortic valve (BAV) patients often develop aortic aneurysms earlier, as early as age 40-50, whereas tricuspid aortic valve (TAV) patients generally present with a degenerative condition that appears later (after age 50). The objective of this study is to compare the inflammatory, metabolic, and transcriptomic signatures of myeloid cells and total aortic tissue between BAV and TAV patients. These analyses will help identify specific molecular mechanisms, potential biomarkers, and therapeutic targets. To ensure pathophysiological homogeneity, patients with aneurysms of genetic origin (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.) will be excluded.

Study Overview

• Status: Recruiting
• Conditions: Ascending Aortic Aneurysm
• Intervention / Treatment: Procedure: Additional blood samples; Procedure: Collection of discarded ascending aortic tissue

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Comlan BLITTI; Phone Number: +33 03.80.29.33.52; Email: comlanmawuko.blitti@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourgogne
    • Contact: Aline LAUBRIET-JAZAYERI; Phone Number: +33 03.80.28.12.94; Email: aline.laubriet@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ascending aortic aneurysms

Description

Inclusion Criteria:

• Individuals who have given their consent
• Patients with an ascending aortic aneurysm for which surgical replacement is indicated
• Age > 18 years
• Scheduled surgery
• Preoperative ultrasound confirmation of the heart valve architecture (bicuspid or tricuspid valve)

Exclusion Criteria:

• A person subject to a legal protective measure (guardianship, conservatorship)
• A person subject to a judicial safeguard measure - A pregnant woman, a woman in labor, or a breastfeeding woman
• Adults who are legally incapacitated or unable to give consent
• Emergency surgical procedures
• Patients with uncontrolled inflammatory or autoimmune conditions
• Patients with a history of recent acute infection (within the last 3 months or still undergoing treatment)
• Patients with a condition requiring immunosuppressants - Patients with a confirmed or suspected genetic aneurysm (Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome, etc.)
• Patients with a history of cardiac surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV)	Procedure: Additional blood samples; Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.; Procedure: Collection of discarded ascending aortic tissue; The aneurysmal portion of the ascending aorta (surgical specimen), which would otherwise be discarded, is collected for research purposes. No other tissue is collected, and the research protocol does not alter the surgical procedure.
Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV)	Procedure: Additional blood samples; Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.; Procedure: Collection of discarded ascending aortic tissue; The aneurysmal portion of the ascending aorta (surgical specimen), which would otherwise be discarded, is collected for research purposes. No other tissue is collected, and the research protocol does not alter the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue	At the time of surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aneurysm, Ascending Aorta
• Other Study ID Numbers: BLITTI 2026-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No