Metformin therapy to prohibit progression in patients with abdominal aortic aneurysm
Phase 1
- Conditions
- Abdominal aortic aneurysmTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001788-19-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
Infrarenal AAA of 3-4.9 cm maximum diameter
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170
Exclusion Criteria
premenopausal female patients with a pregnancy possibility
• patients with diabetes
• indication for surgical AAA repair
• life expectancy <2 years
• contraindications for metformin, i.e. severly reduced kidney
function (eGFR <30 ml/min), liver dysfunction, pancreatitis,
alcohol abusus, malnutrition and decompensated heart failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Metformin therapy to inhibit progression in patients with abdominal aortic aneurysma;Secondary Objective: subsets of neutrophils will be detected by immunostaining of surface<br>markers (such as CD66b, CD16, CD62L and ICAM-1)<br>platelet-surface marker (like CD41<br>Neutrophil and NET parameters such as citrullinated histone H3,<br>oxidized mitochondrial DNA and elastase;Primary end point(s): AAA growth at 12 months in mm;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Neutrophil activation and NETs at 6 and 12 months;Timepoint(s) of evaluation of this end point: 6 and 12 months