Status:
RECRUITING
Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture
Lead Sponsor:
RenJi Hospital
Conditions:
Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The objective of this project is to define whether nutritional supplement (oral administration with alpha-ketoglutarate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve o...
Detailed Description
Abdominal aortic aneurysm (AAA) is an age-related disease that characterized by permanent regional dilation of the abdominal aortae, which results in catastrophic event of rupture and sudden death. Cu...
Eligibility Criteria
Inclusion
- Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
- Han nationality;
- Between 50 years or more, no gender limit;
- No mental illness;
- No history of supplement allergy or supplement allergy;
- Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion
- Previous infrarenal aortic surgery;
- Planned major surgery;
- Known aortic dissection;
- Have received any other clinical trial treatment within 1 year;
- Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
- Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
- Known or suspected inherited connective tissue disorder;
- Calculated creatinine clearance of less than 30 ml/min;
- Known significant liver disease;
- Known human immunodeficiency virus infection at the time of screening；
- Serious concomitant illness associated with life expectancy of less than 2 years；
- Any other significant and unstable condition that could limit compliance with the trial protocol.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04723888
Start Date
February 1 2021
End Date
December 31 2026
Last Update
February 21 2021
Active Locations (1)
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1
Cardiology, Ren Ji Hospital
Shanghai, China