Chronic Kidney Disease, Pulmonary Hypertension
Conditions
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.
Interventions
OTHERNo intervention is planned as part of the study
No intervention is planned as part of the study
Sponsors
University of Giessen
Icahn School of Medicine at Mount Sinai
University of Virginia
Kerckhoff Klinik
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse kidney events | 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 kidney-related death |
| Worsening PH or HF | 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), or worsening of PH as diagnosed by right heart catheterization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Baseline to 12 months | Number of patients experiencing all-cause mortality during follow-up |
| Kidney function decline | 12 months | Number of patients with 50% decline in eGFR from baseline and the eGFR slope at 12 months |
| Pulmonary hypertension-related death | 12 months | Death attributed to pulmonary hypertension |
Countries
Germany
Contacts
CONTACTFaeq Husain-Syed, MD
CONTACTBirgit Jennert, MLA
PRINCIPAL_INVESTIGATORFaeq Husain-Syed, MD
University of Giessen
Outcome results
None listed