Telmisartan in the management of abdominal aortic aneurysm

The effects of Telmisartan, an angiotensinII type 1 receptor blocker, in reducing AAA growth in patients with abdominal aortic aneurysm.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000931976

Acronym

TEDY

Enrollment

208

Registered

2011-08-30

Start date

2011-09-09

Completion date

2016-10-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to investigate telmisartan as a novel therapy for patients with abdominal aortic aneurysms. We hypothesize that telmisartan will reduce AAA growth.

Interventions

Angiotensin II type 1 receptor blocker, oral tablet, 40mg daily for 24 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Written informed consent 2. Infra-renal AAA measuring a maximum orthogonal diameter greater than or equal to 35mm and less than or equal to 49mm on CTA or ultrasound; 3. Stable medication regime for the last 6 months; 4. No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year; 5. High likelihood of compliance with treatment over 24 months.

Exclusion criteria

Contraindications to study treatment, including: 1. renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN]), 2. known significant renal stenosis (>70%) of one or both renal arteries, 3. chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN), 4. electrolyte imbalance and 5. active gout; 6. Current or planned usage of an AT1 blocker 7. Current or planned usage of an ACE inhibitor. 8. If the patient has previously had abdominal aortic surgery

Outcome results