Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

Recruiting

• Conditions: Pulmonary Hypertension; Chronic Kidney Disease
• Interventions: Other: No intervention is planned as part of the study

• Registration Number: NCT06409624
• Lead Sponsor: University of Giessen

Brief Summary

The objective of this study is to examine the association between urinary and plasma biomarkers and change in estimated glomerular filtration rate (eGFR) among patients with pulmonary hypertension (PH).

Detailed Description

PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Kidney disease is present in approximately 35% of 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.

There is a crucial need to better understand the pathophysiological mechanisms linking the failing right heart and the kidney. To date, diagnostic and prognostic biomarkers of kidney disease in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and change in eGFR among patients with PH.

Study Timeline

• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-10
• Study Start: 2024-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Inpatients aged ≥18 years
• Undergoing right heart catheterization (RHC)

Exclusion Criteria

• Active tumor disease requiring targeted therapy
• inflammatory or autoimmune disease with renal involvement requiring systemic immunosuppressive treatment
• Chronic kidney disease 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
• prediagnosed 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
• refusal to participate
• not available for follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary hypertension	No intervention is planned as part of the study	Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment
No pulmonary hypertension	No intervention is planned as part of the study	Patients in whom PH was excluded by right heart catheterization

Primary Outcome Measures

Name	Time	Method
Major adverse kidney events	Baseline to 12 months	Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Initiation of dialysis	Baseline to 12 months	Number of patients requiring initiation of dialysis during follow-up
All-cause mortality	Baseline to 12 months	Number of patients experiencing all-cause mortality during follow-up
Kidney function decline	12 months	Number of patients with eGFR decline ≥25% from baseline

Trial Locations

Locations (1)

University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II; 🇩🇪 Giessen, Hessen, Germany