Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

N/AActive Not RecruitingNCT06409624

University of Giessen350 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

350

Conditions

Pulmonary Hypertension Chronic Kidney Disease

Interventions

No intervention is planned as part of the studyOTHER

No intervention is planned as part of the study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * unexplained kidney function decline, defined as serum creatinine increase ≥0.5 mg/dL from baseline within the prior 7 days before RHC * 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 * single kidney (functional or anatomical) * 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 * inability to cooperate with respiratory maneuvers during renal Doppler * refusal to participate * not available for follow-up visits

Locations (1)

University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II

Giessen, Hesse, Germany

Outcomes

Primary Outcomes

Major adverse kidney events

Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or all-cause mortality

Time frame: Baseline to 12 months

Secondary Outcomes

Initiation of dialysis

Number of patients requiring initiation of dialysis during follow-up

Time frame: Baseline to 12 months

All-cause mortality

Number of patients experiencing all-cause mortality during follow-up

Time frame: Baseline to 12 months

Kidney function decline

Number of patients with eGFR decline ≥25% from baseline

Time frame: 12 months

Data from ClinicalTrials.gov

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