NCT04197648 Effects of Exercise on Thoracic Aneurysms
| NCT ID | NCT04197648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Thoracic Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-10 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Thoracic aneurysm incidence is estimated to 4.5 cases per 100 000. The manifestation as well as natural history of thoracic aneurysm depend on many factors such as its localisation, its diameter, presence of collagen disease and family history. For the ascendant aortic aneurysm, it is often linked to a degeneration of the media arterial layer of the arterial wall. The media degeneration is cause by the degeneration of the elastic fibres, which lead to a weakening of the arterial wall accompanied with dilation. This process is often due to age and is accelerated by high blood pressure. Amongst the numerous factors causing the aneurysm, the investigators find: hypertension, aortic bicuspid valve, smoking, atherosclerosis, trauma and genetic predisposition. The average growth rate of thoracic aneurysm is 0.1-0.2 cm/year. The risk of rupture is associated to the size of the aneurysm as well as patient's symptoms. The ruptures and dissections rates are accounted for 2-3/year for thoracic aneurysm between 5.5-6.0 cm in diameter. The patients are often limited in their daily life activities considering their concern and risk of rupture and/or dissect. The effects of exercise on the progression of the aneurysm dilation in patients with thoracic ascendant aortic aneurysm are unknown. It is well known that high blood pressure is a risk factor for rupture of the aortic aneurysm. Many studies have demonstrated the benefits of physical exercise regarding the lowering impact of blood pressure in a cardiac hypertensive population. At 3 and 6 months of the intervention, the subjects in the exercise group will have: 1) a lowered blood pressure at rest and during exercise, 2) maintenance/ improvement of muscle strength, 3) improvement of aerobic exercise capacity (VO2max), and 4) aortic dilation that remained stable or comparable to the control group. The research objective is to measure and compare to a control group, the effects of an exercise program on the following parameters: blood pressure response at rest and during exercise, as well as the VO2max at 3 and 6 months time of the intervention. This randomised and prospective study will take place at the " Institut Universitaire de Cardiologie et de Pneumologie du Québec (IUCPQ) " and will include patients who have a non-surgical ascendant thoracic aortic aneurysm (ATAA). The selected subjects will be randomised into two groups: 1) exercise group (n=15), and 2) control group (n=15). Both groups will be met prior to the intervention (baseline) and at 3 and 6 months time of the intervention, and measures described below will be recorded.
Eligibility Criteria
Inclusion Criteria: * 18 years and older * Have an interest in participating in a supervised exercise training program * Aortic diameter between 3,5 and 5 cm Exclusion Criteria * Glomerular filtration rate below 30 mL/min/1.73m² * Aortic diameter greater than or equal to 5.1 cm * Progression of aortic diameter greater than or equal to 0.5 cm per year * Allergy to iodine * Aortic valve bicuspidy * History of aortic surgery or cardiac surgery * Presence of an aortic dissection, penetrating aortic ulcer, or intra-mural hematoma of the aorta * Presence of Marfan syndrome or other genetic and/or congenital disease explaining the thoracic aortic aneurysm * History of stroke * Presence of peripheral artery disease * History and/or presence of aortitis * Known diagnosis of temporal arteritis or rheumatoid arthritis * Presence of a pacemaker * Major cognitive limitation that may affect adherence to visits * Musculoskeletal limitation that restricts participation in the training program
Contact & Investigator
Paul Poirier, MD
PRINCIPAL INVESTIGATOR
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Frequently Asked Questions
Who can join the NCT04197648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04197648 currently recruiting?
Yes, NCT04197648 is actively recruiting participants. Contact the research team at paul.poirier@criucpq.ulaval.ca for enrollment information.
Where is the NCT04197648 trial being conducted?
This trial is being conducted at Québec, Canada, Québec, Canada.
Who is sponsoring the NCT04197648 clinical trial?
NCT04197648 is sponsored by Laval University. The principal investigator is Paul Poirier, MD at Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The trial plans to enroll 30 participants.