Abdominal Aortic Aneurysm Clinical Trial
Official title:
An Evaluation of the Effect of an Angiotensin-converting Enzyme (ACE) Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms.
Abdominal aortic aneurysms (AAA) are balloon-like swellings of the body's main blood vessel (aorta) as it courses through the abdomen. As a result of the National Aneurysm Screening programme many more of these will be detected. Small AAAs grow slowly and remain a benign condition until the diameter exceeds 2-3 times the diameter of the normal aorta (about 5.5cm in size), when operative repair of the aneurysm is recommended avoiding the potentially fatal event of bursting and bleeding (aneurysm rupture). It is therefore important to identify a strategy to prevent aneurysm growth. There is a suggestion that the use of a specific drug class, angiotensin converting enzyme (ACE) inhibitors, may reduce the risk of rupture of the larger aneurysms. This trial will assess whether an ACE inhibitor (perindopril) has aneurysm-related benefits, in patients with small AAAs at screening centres in the London area. The effects of perindopril versus a placebo(dummy) on AAA growth rates will be compared. In addition by comparing the effects of perindopril with the effects of equivalent blood pressure lowering with another non-ACE inhibitor class of drug (amlodipine) on aneurysm growth rate, we can see whether any benefits of perindopril are simply the result of lowering blood pressure. 225 Patients will be assigned to one of these 3 treatments by chance (randomisation).In addition to analysis of the effect of perindopril and blood pressure lowering,the effect of the treatments on quality of life will be assessed. Patients will return at 3-monthly intervals for an ultrasound scan and blood pressure measurements, with questionnaires regarding quality of life at the start and end of the 2-year research period. An ultrasound scan is a painless test that uses sound waves to create images of organs and structures inside your body.
This trial will investigate the idea that an ACE-inhibitor reduces abdominal aortic aneurysm (AAA) growth rate, in a pilot 3-arm randomised controlled trial (i.e. the study treatment is chosen by random for each patient). The three interventions are ACE-inhibition with perindopril; equivalent blood pressure reduction with amlodipine (a calcium channel blocker) and a placebo tablet. By comparing the effects in the perindopril and amlodipine arms, this design will permit an evaluation of any blood pressure independent effects of perindopril. Pending results of this pilot trial, we plan to work with the local and National Aneurysm Screening programme to conduct a larger, definitive trial, to investigate the hypothesis that blood pressure reduction with an ACE-inhibitor slows the rate of small AAA growth preferentially compared with other antihypertensive agents. Secondary research questions in this trial are the effects of perindopril therapy on aneurysm-related death rates, other diseases possibly caused by an AAA and quality of life compared to similar blood pressure lowering effects with amlodipine and placebo. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04227054 -
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
|
N/A | |
Active, not recruiting |
NCT03687489 -
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
|
N/A | |
Active, not recruiting |
NCT03507413 -
Metformin Therapy in Non-diabetic AAA Patients
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05756283 -
The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair
|
N/A | |
Not yet recruiting |
NCT04089241 -
Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair
|
N/A | |
Active, not recruiting |
NCT02604303 -
A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
|
||
Terminated |
NCT02469376 -
Evaluation of a New Imagingtechnologie for Thrombosis
|
Phase 1 | |
Completed |
NCT02229006 -
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
|
N/A | |
Completed |
NCT02224794 -
LIFE Study: Least Invasive Fast-Track EVAR
|
||
Terminated |
NCT01843335 -
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
|
N/A | |
Terminated |
NCT01425242 -
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
|
N/A | |
Completed |
NCT00746122 -
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
|
N/A | |
Completed |
NCT03952780 -
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
|
||
Completed |
NCT00583414 -
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
|
N/A | |
Recruiting |
NCT05864560 -
Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
|
||
Completed |
NCT01683084 -
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
|
Phase 4 | |
Active, not recruiting |
NCT03180996 -
Global Fenestrated Anaconda Clinical sTudy
|
||
Completed |
NCT02493296 -
The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
|
||
Completed |
NCT03320408 -
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
|
||
Completed |
NCT03837704 -
Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking.
|
N/A |