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OpenTrials
Active, Not Recruiting

NCT Number: NCT06409624

Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pulmonary Kidney Diseases Lung Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention is planned as part of the study

Other

No intervention is planned as part of the study

Primary outcomes

  1. Major adverse kidney events

    Time frame: 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 outcomes

  1. Initiation of dialysis

    Time frame: Baseline to 12 months

    Number of patients requiring initiation of dialysis during follow-up

  2. All-cause mortality

    Time frame: Baseline to 12 months

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

  3. Kidney function decline

    Time frame: 12 months

    Number of patients with eGFR decline ≥25% from baseline

Other outcomes

  1. Worsening PH

    Time frame: Baseline to 12 months

    Number of patients experiencing worsening of PH, defined as hospitalization due to acute right heart failure, increase in PH-targeted medication or diuretics (outpatient or inpatient), worsening of PH as diagnosed by right heart catheterization, or cardiovascular death

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • University of Virginia

Registry information

Official study title

Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 10, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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