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Not yet recruiting NCT07104968

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

Observational Aortic Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Regurgitation. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Primary outcome measures

  • Progress of aortic regurgitation [Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up]
Secondary outcome measures (4)
  • 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]
  • Hospitalization for heart failure [Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up]
  • Hospitalization for stroke or myocardial infarction [Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up]
  • All-cause mortality [Time frame: Depending on when the patients was evaluated first, up to approximately 20 years of follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Västmanlands sjukhus Västerås — Västerås

Publications

  • 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. PMID 31727286
  • 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. PMID 10190406

Identifiers

NCT: NCT07104968 · 2025-02671-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗