Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

University of Giessen

Status: Active, not recruiting

Conditions: Chronic Kidney Disease; Pulmonary Hypertension

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

Study type: Observational

Funder types: Other

Identifiers

NCT06409624

AZ174/18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

Pulmonary hypertension

Description:

Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment

Treatment:

Other: No intervention is planned as part of the study

No pulmonary hypertension

Description:

Patients in whom PH was excluded by right heart catheterization

Treatment:

Other: No intervention is planned as part of the study