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NCT Number: NCT07104968

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progress of aortic regurgitation

    Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

    Progress 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 outcomes

  1. Surgical treatment of aortic regurgitation or aortic aneurysm

    Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

    Surgical treatment of aortic regurgitation or aortic aneurysm

  2. Hospitalization for heart failure

    Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

    Hospitalization for heart failure during follow-up

  3. Hospitalization for stroke or myocardial infarction

    Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

    Composite endpoint

  4. All-cause mortality

    Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up

    All-cause mortality during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Matthijs Velders, MD PhD

CONTACT

[email protected]

+4621-175947

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Region Västmanland

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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