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Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome

Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07104968
Enrollment
35000
Registered
2025-08-05
Start date
2025-08-01
Completion date
2026-04-01
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Regurgitation

Brief summary

This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation

Detailed description

Aortic regurgitation is relatively common, with a prevalence of 13% for men and 8,5% for women in the Framingham study (Singh et al). Patients with aortic regurgitation are evaluated regularly with echocardiography to see if progress occurs, and suitable candidates are referred for surgical repair or replacement of the aortic valve. However, an American study from 2019 showed that only 12% of cases of aortic regurgitation progressed from mild to moderate or severe over a 10 years period (Yang et al). This means that the majority of patients undergo echocardiographic evaluations without a clinical benefit. It is unclear whether these findings also apply to a Swedish population with the European definitions for aortic regurgitation. Aim: To do a retrospective analysis of patients evaluated with echocardiography in Västerås, Sweden between January 2003 and March 2025 to describe the prevalence of aortic regurgitation as well as aortic dilatation, to describe how often progress occurs in patients with mild or moderate aortic regurgitation, and finally to look at factors (clinical, echocardiographic) associated with progress of aortic regurgitation as well as outcome (mortality, MACE, cardiac surgery).

Interventions

None listed

Sponsors

Region Västmanland
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients investigated with echocardiography between January 2003 and March 2025 * Age ≥18 years * At least minimal aortic regurgitation * At least one additional echocardiography after the index investigation

Exclusion criteria

* Age \<18 years

Design outcomes

Primary

MeasureTime frameDescription
Progress of aortic regurgitationDepending on when the patients was evaluated first, up to approximately 20 years of follow-upProgress of aortic regurgitation from mild to moderate or severe, or moderate to severe. Progress is defined according to current European Society for Cardiology guidelines using a comprehensive echocardiographic assessment

Secondary

MeasureTime frameDescription
Surgical treatment of aortic regurgitation or aortic aneurysmDepending on when the patients was evaluated first, up to approximately 20 years of follow-upSurgical treatment of aortic regurgitation or aortic aneurysm
Hospitalization for heart failureDepending on when the patients was evaluated first, up to approximately 20 years of follow-upHospitalization for heart failure during follow-up
Hospitalization for stroke or myocardial infarctionDepending on when the patients was evaluated first, up to approximately 20 years of follow-upComposite endpoint
All-cause mortalityDepending on when the patients was evaluated first, up to approximately 20 years of follow-upAll-cause mortality during follow-up

Countries

Sweden

Contacts

Primary ContactMatthijs Velders, MD PhD
matthijs.velders@regionvastmanland.se+4621-175947

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026