Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT04723888

Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture

Led by RenJi Hospital · Updated on 2021-02-21

300

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 outcomes in patients with an abdominal aortic aneurysm of 39-49 mm in diameter on ultrasound imaging. Alpha-ketoglutarate is commonly used as a nutritional supplement specially by athletes to increase muscle strength. They can be mixed with formula or other foods. Subjects will be followed for up to 5 years.

CONDITIONS

Official Title

Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
  2. Han nationality;
  3. Between 50 years or more, no gender limit;
  4. No mental illness;
  5. No history of supplement allergy or supplement allergy;
  6. Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Not Eligible

You will not qualify if you...

  1. Previous infrarenal aortic surgery;
  2. Planned major surgery;
  3. Known aortic dissection;
  4. Have received any other clinical trial treatment within 1 year;
  5. Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
  6. Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
  7. Known or suspected inherited connective tissue disorder;
  8. Calculated creatinine clearance of less than 30 ml/min;
  9. Known significant liver disease;
  10. Known human immunodeficiency virus infection at the time of screening;
  11. Serious concomitant illness associated with life expectancy of less than 2 years;
  12. Any other significant and unstable condition that could limit compliance with the trial protocol.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cardiology, Ren Ji Hospital

Shanghai, China

Actively Recruiting

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Research Team

J

Jun Pu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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