Ascending Aortic AneurysmPROMETANCT07695545
A 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.
An observational study of Ascending Aortic Aneurysm, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascending Aortic Aneurysm
- What is being tested?
- Additional blood samples and Collection of discarded ascending aortic tissue
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2026to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ascending aortic aneurysms
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Aline LAUBRIET-JAZAYERI, 03.80.28.12.94 ext. +33, aline.laubriet@chu-dijon.fr
About this study
Official title: 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.
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.
- Conditions
- Ascending Aortic Aneurysm
- Being tested
- Additional blood samples, Collection of discarded ascending aortic tissue
- Medical subject headings
- Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplesProcedure or surgery
Additional blood sample are collected at the time of routine clinical blood sampling for recherche analyses.
Collection of discarded ascending aortic tissueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV) | Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV) Receives: Procedure: Additional blood samples; Procedure: Collection of discarded ascending aortic tissue | |
| Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) | Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) Receives: Procedure: Additional blood samples; Procedure: Collection of discarded ascending aortic tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start28 Jun 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695545
- Sponsor's protocol ID
- BLITTI 2026-1
- Acronym
- PROMETA
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07695545
- Acronym / sponsor ID
- PROMETA / BLITTI 2026-1
- Conditions
- Ascending Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 28 Jun 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV) | – | Procedure: Additional blood samples, Procedure: Collection of discarded ascending aortic tissuePatient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV) |
| Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) | – | Procedure: Additional blood samples, Procedure: Collection of discarded ascending aortic tissuePatient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ascending aortic aneurysms
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood samplesAdditional blood sample are collected at the time of routine clinical blood sampling for recherche analyses. | Procedure or surgery | Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV), Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) |
| Collection of discarded ascending aortic tissueThe 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. | Procedure or surgery | Patient with an ascending aortic aneurysm and a bicuspid aortic valve (BAV), Patient with an ascending aortic aneurysm and a tricuspid aortic valve (TAV) |
Primary outcome
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue
Time frame: At the time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascending Aortic Aneurysm, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Comlan BLITTI (03.80.29.33.52 ext. +33, comlanmawuko.blitti@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory, metabolic, and transcriptomic markers of myeloid cells and aortic tissue (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.