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Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT04224675
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Spartalis, Onassis Cardiac Surgery Centre

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.


Condition or disease Intervention/treatment Phase
Aneurysm Drug: Atenolol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
Estimated Study Start Date : March 7, 2020
Estimated Primary Completion Date : March 7, 2023
Estimated Study Completion Date : March 7, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ate Drug: Atenolol
Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms
Other Name: Captopril

Cap Drug: Atenolol
Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms
Other Name: Captopril




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Spartalis, MD, MSc, FESC, FEHRA, FACC, CCDS, Onassis Cardiac Surgery Centre
ClinicalTrials.gov Identifier: NCT04224675    
Other Study ID Numbers: OnassisCSC
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Atenolol
Captopril
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors