Association Between Biomarkers and eGFR Decline in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Association Between Biomarkers and Decline in Estimated Glomerular Filtration Rate in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409624
• Other study ID #: AZ174/18
• Status: Recruiting
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: University of Giessen
• Contact: Faeq Husain-Syed, MD
• Phone: +49 641 985 42378
• Email: faeq.husain-syed[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to examine the association between urinary and plasma biomarkers and the change of estimated glomerular filtration rate (eGFR) in patients with pulmonary hypertension (PH) as a tool to identify patients at high risk for short-term eGFR decline.

Description:

PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Chronic kidney disease (CKD) is approximately 35% in patients with PH, and its presence is associated with an enhanced risk for adverse outcomes, with the risk increasing incrementally with declining kidney function. Poor right ventricular function may increase venous congestion, alter ventricular interdependence, decrease effective cardiac output and activate the renin-angiotensin- aldosterone system, thereby aggravating kidney disease. To date, biomarkers for assessment of CKD progression in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and the change of eGFR in patients with PH, aiming to identify those at high risk for short-term eGFR decline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients aged =18 years

• undergoing right heart catheterization (RHC)

Exclusion Criteria:

• active tumor disease

• inflammatory or autoimmune disease requiring systemic immunosuppressive treatment

• CKD with eGFR <20 ml/min/1.73 m2

• non-kidney failure requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload

• if they had received non-steroidal anti-inflammatory drugs or intravenous contrast within 72 hours before RHC

• glomerulonephritis

• polycystic kidney disease

• postrenal obstruction

• solid organ transplantation

• anticipated life expectancy of <12 months

• likelihood of receiving advanced therapy (mechanical circulatory assist device/lung or cardiac transplant)

• pregnancy or possibility of pregnancy in the next 12 months

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• No intervention is planned as part of the study
No intervention is planned as part of the study

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Chakinala MM, Coyne DW, Benza RL, Frost AE, McGoon MD, Hartline BK, Frantz RP, Selej M, Zhao C, Mink DR, Farber HW. Impact of declining renal function on outcomes in pulmonary arterial hypertension: A REVEAL registry analysis. J Heart Lung Transplant. 201 — View Citation

Husain-Syed F, DiFrancesco MF, Deo R, Barr RG, Scialla JJ, Bluemke DA, Kronmal RA, Lima JAC, Praestgaard A, Tracy RP, Shlipak M, Kawut SM, Kim JS. Associations between eGFR and albuminuria with right ventricular measures: the MESA-Right Ventricle study. Clin Kidney J. 2023 Apr 21;16(9):1508-1520. doi: 10.1093/ckj/sfad096. eCollection 2023 Sep. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney function decline	Kidney function as assessed by eGFR	Baseline to 12 months
Secondary	Initiation of dialysis	Number of patients requiring initiation of dialysis during follow-up	Baseline to 12 months
Secondary	All-cause mortality	All-cause mortality during follow-up	Baseline to 12 months