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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
Onassis Cardiac Surgery Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aneurysm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 8, 2020
    Last Updated
    January 8, 2020
    Sponsor
    Onassis Cardiac Surgery Centre
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    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

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    Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms

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