Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
Primary Purpose
Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atenolol
Sponsored by
About this trial
This is an interventional prevention trial for Aneurysm
Eligibility Criteria
Inclusion Criteria:
All adult men or women, aged at least 70 years, with TAA 3.0-5.5 cm in diameter measurements according to magnetic resonance imaging (MRI) of the aorta and with a systolic BP < 150 mmHg will be eligible for inclusion in the study.
Exclusion Criteria:
Patients already receiving an ACEI or BB daily, patients with known renal artery stenosis (> 50%), patients incapable of providing informed consent, history of aortic dissection, angioedema or any intolerance to ACEIs or BBs, asthma, pregnancy, frailty, respiratory failure, and renal failure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Ate
Cap
Arm Description
Outcomes
Primary Outcome Measures
rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol
Secondary Outcome Measures
Full Information
NCT ID
NCT04224675
First Posted
January 8, 2020
Last Updated
January 8, 2020
Sponsor
Onassis Cardiac Surgery Centre
1. Study Identification
Unique Protocol Identification Number
NCT04224675
Brief Title
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
Official Title
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2020 (Anticipated)
Primary Completion Date
March 7, 2023 (Anticipated)
Study Completion Date
March 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onassis Cardiac Surgery Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. Current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder. Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm.
The study will be a randomized, double-blind trial. Patients will be randomized into one of two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol.
BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties.
The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ate
Arm Type
Other
Arm Title
Cap
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Atenolol
Other Intervention Name(s)
Captopril
Intervention Description
Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms
Primary Outcome Measure Information:
Title
rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adult men or women, aged at least 70 years, with TAA 3.0-5.5 cm in diameter measurements according to magnetic resonance imaging (MRI) of the aorta and with a systolic BP < 150 mmHg will be eligible for inclusion in the study.
Exclusion Criteria:
Patients already receiving an ACEI or BB daily, patients with known renal artery stenosis (> 50%), patients incapable of providing informed consent, history of aortic dissection, angioedema or any intolerance to ACEIs or BBs, asthma, pregnancy, frailty, respiratory failure, and renal failure.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32842783
Citation
Spartalis M, Tzatzaki E, Iliopoulos DC, Spartalis E, Patelis N, Athanasiou A, Paschou SA, Voudris V, Siasos G. Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms: rationale and design. Future Cardiol. 2021 Mar;17(2):189-195. doi: 10.2217/fca-2020-0062. Epub 2020 Aug 25.
Results Reference
derived
Learn more about this trial
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
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