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Clinical Trials/NCT04571372
NCT04571372CompletedNot Applicable

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

Yonsei University2 sites in 2 countries222 target enrollmentStarted: August 14, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
222
Locations
2
Primary Endpoint
Number of participants with adverse clinical outcomes
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients with severe aortic stenosis or severe aortic regurgitation

Patients with severe aortic stenosis or severe aortic regurgitation

Outcomes

Primary Outcomes

Number of participants with adverse clinical outcomes

Time Frame: 2 years after recruiting

Composite of all-cause death, cardiovascular mortality, and worsening of kidney function

Number of participants with adverse clinical outcomes

Time Frame: Immediate post operation

Composite of all-cause death, cardiovascular mortality, and worsening of kidney function

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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