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

Severe Aortic Stenosis or Severe Aortic Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571372
• Other study ID #: 4-2020-0620
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: August 2023

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Jiwon Seo
• Phone: 82-2-2228-8464
• Email: jiwonseo1430[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Severe Aortic Stenosis or Severe Aortic Regurgitation

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

Koller L, Stojkovic S, Richter B, Sulzgruber P, Potolidis C, Liebhart F, Mörtl D, Berger R, Goliasch G, Wojta J, Hülsmann 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. — View Citation

Outcome

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