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

NCT ID: NCT07104968

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 35000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-04-01

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).

Conditions

Aortic Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with aortic regurgitation

Observational study, no interventions

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västmanland

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Pär Hedberg

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthijs Velders, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Region Västmanland

Locations

Västmanlands sjukhus Västerås

Västerås, , Sweden

Countries

Sweden

Central Contacts

Matthijs Velders, MD PhD

Role: CONTACT

matthijs.velders@regionvastmanland.se

+4621-175947

Facility Contacts

Matthijs Velders, MD PhD

Role: primary

matthijs.velders@regionvastmanland.se

+4621-175947

References

Yang LT, Enriquez-Sarano M, Michelena HI, Nkomo VT, Scott CG, Bailey KR, Oguz D, Wajih Ullah M, Pellikka PA. Predictors of Progression in Patients With Stage B Aortic Regurgitation. J Am Coll Cardiol. 2019 Nov 19;74(20):2480-2492. doi: 10.1016/j.jacc.2019.08.1058.

Reference Type: BACKGROUND

PMID: 31727286 (View on PubMed)

Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999 Mar 15;83(6):897-902. doi: 10.1016/s0002-9149(98)01064-9.

Reference Type: BACKGROUND

PMID: 10190406 (View on PubMed)

Other Identifiers

2025-02671-01

Identifier Type: -

Identifier Source: org_study_id