Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease

This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)

Study Overview

• Status: Completed
• Conditions: Severe Aortic Stenosis or Severe Aortic Regurgitation

• Study Type: Observational
• Enrollment (Actual): 222

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with severe aortic stenosis or severe aortic regurgitation

Description

Inclusion Criteria:

• Age ≥ 19 yrs
• Severe aortic stenosis or severe aortic regurgitation
• Agree to consent for self
• Can follow-up for the next 2 years

Exclusion Criteria:

• Pre-existing acute kidney injury
• Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy
• On ECMO or IABP
• Life expectancy < 12 months
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with severe aortic stenosis or severe aortic regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse clinical outcomes	Composite of all-cause death, cardiovascular mortality, and worsening of kidney function	Immediate post operation
Number of participants with adverse clinical outcomes	Composite of all-cause death, cardiovascular mortality, and worsening of kidney function	2 years after recruiting

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Koller L, Stojkovic S, Richter B, Sulzgruber P, Potolidis C, Liebhart F, Mortl D, Berger R, Goliasch G, Wojta J, Hulsmann M, Niessner A. Soluble Urokinase-Type Plasminogen Activator Receptor Improves Risk Prediction in Patients With Chronic Heart Failure. JACC Heart Fail. 2017 Apr;5(4):268-277. doi: 10.1016/j.jchf.2016.12.008.
• Hayek SS, Sever S, Ko YA, Trachtman H, Awad M, Wadhwani S, Altintas MM, Wei C, Hotton AL, French AL, Sperling LS, Lerakis S, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Chronic Kidney Disease. N Engl J Med. 2015 Nov 12;373(20):1916-25. doi: 10.1056/NEJMoa1506362. Epub 2015 Nov 5.
• Hayek SS, Leaf DE, Samman Tahhan A, Raad M, Sharma S, Waikar SS, Sever S, Camacho A, Wang X, Dande RR, Ibrahim NE, Baron RM, Altintas MM, Wei C, Sheikh-Hamad D, Pan JS, Holliday MW Jr, Januzzi JL, Weisbord SD, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Acute Kidney Injury. N Engl J Med. 2020 Jan 30;382(5):416-426. doi: 10.1056/NEJMoa1911481.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): December 13, 2025
• Study Completion (Actual): December 13, 2025

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: 4-2020-0620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No