RecruitingRecruiting
Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension
NCT06409624 · University of Giessen
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension
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.
Eligibility criteria
Inclusion Criteria:
* Inpatients aged ≥18 years
* Undergoing right heart catheterization (RHC)
Exclusion Criteria:
* multifactorial or indeterminate PH, for which no single underlying mechanism could be reliably classified
* 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
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-05-31
Estimated completion: 2027-12
Last updated: 2026-09-08
Interventions
Other: No intervention is planned as part of the study
Primary outcomes
- • Major adverse kidney events (Baseline to 12 months)
- • Worsening PH or HF (Baseline to 12 months)
Sponsor
University of Giessen · other
With: Icahn School of Medicine at Mount Sinai, University of Virginia, Kerckhoff Klinik, Universitätsklinikum Hamburg-Eppendorf
Contacts & investigators
ContactFaeq Husain-Syed, MD · contact · faeq.husain-syed@innere.med.uni-giessen.de · +49 641 985 42378
ContactBirgit Jennert, MLA · contact · birgit.jennert@innere.med.uni-giessen.de · +49 641 985 42378
InvestigatorFaeq Husain-Syed, MD · principal_investigator, University of Giessen
All locations (2)
Kerckhoff Klinik Heart and Thorax CenterRecruiting
Bad Nauheim, Hesse, Germany
University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine IIRecruiting
Giessen, Hesse, Germany