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

NCT07104968 | Not Yet Recruiting

• 1 other identifier: 2025-02671-01
• Study Type: observational
• Target: 35,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• Progress of aortic regurgitation

  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

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

Secondary Outcomes (4)

• Surgical treatment of aortic regurgitation or aortic aneurysm

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

• Hospitalization for heart failure

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

• Hospitalization for stroke or myocardial infarction

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

• All-cause mortality

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

Study Arms (1)

Patients with aortic regurgitation

Observational study, no interventions

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with aortic regurgitation

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Uppsala University: lead
• Region Västmanland: collaborator

Study Sites (1)

Västmanlands sjukhus Västerås

Västerås, Sweden

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Matthijs Velders, MD PhD

  Region Västmanland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthijs Velders, MD PhD

CONTACT

+4621-175947; matthijs.velders@regionvastmanland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

SE (1)