Clinical trial NCT06409624: Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension
Official title: Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Chronic Kidney Disease
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: University of Virginia
First posted: 2024-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients admitted at University Hospital Giessen and Marburg, Campus Giessen with suspected or pre-diagnosed PH undergoing RHC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse kidney events
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Initiation of dialysis
timeFrame: Baseline to 12 months
measure: All-cause mortality
timeFrame: Baseline to 12 months
measure: Kidney function decline
timeFrame: 12 months
Other outcomes:
measure: Worsening PH
timeFrame: Baseline to 12 months
Locations:
city: Giessen
country: Germany
facility: University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II
state: Hessen
Study officials:
affiliation: University of Giessen
name: Faeq Husain-Syed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. 2018 Jun;37(6):696-705. doi: 10.1016/j.healun.2017.10.028. Epub 2017 Nov 6.