Association Between Biomarkers and eGFR Decline in Pulmonary Hypertension

Association Between Biomarkers and Decline in Estimated Glomerular Filtration Rate in Patients With Pulmonary Hypertension

The objective of this study is to examine the association between urinary and plasma biomarkers and the change of estimated glomerular filtration rate (eGFR) in patients with pulmonary hypertension (PH) as a tool to identify patients at high risk for short-term eGFR decline.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Other: No intervention is planned as part of the study

Detailed Description

PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Chronic kidney disease (CKD) is approximately 35% in 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. To date, biomarkers for assessment of CKD progression in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and the change of eGFR in patients with PH, aiming to identify those at high risk for short-term eGFR decline.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Faeq Husain-Syed, MD; Phone Number: +49 641 985 42378; Email: faeq.husain-syed@innere.med.uni-giessen.de
• Study Contact Backup: Name: Birgit Jennert, MLA; Phone Number: +49 641 985 42378; Email: birgit.jennert@innere.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Giessen, Hessen, Germany, 35392
      • Recruiting
      • University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II
      • Contact: Faeq Husain-Syed, MD; Phone Number: +49 641 985 42378; Email: faeq.husain-syed@innere.med.uni-giessen.de
      • Contact: Birgit Jennert, MLA; Phone Number: +49 641 985 42378; Email: birgit.jennert@innere.med.uni-giessen.de
      • Principal Investigator: Faeq Husain-Syed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Inpatients admitted at University Hospital Giessen and Marburg, Campus Giessen with suspected or pre-diagnosed PH undergoing RHC

Description

Inclusion Criteria:

• Inpatients aged ≥18 years
• undergoing right heart catheterization (RHC)

Exclusion Criteria:

• active tumor disease
• inflammatory or autoimmune disease requiring systemic immunosuppressive treatment
• CKD 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary hypertension; Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment	Other: No intervention is planned as part of the study; No intervention is planned as part of the study
No pulmonary hypertension; Patients in whom PH was excluded by right heart catheterization	Other: No intervention is planned as part of the study; No intervention is planned as part of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney function decline	Kidney function as assessed by eGFR	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Faeq Husain-Syed, MD, University of Giessen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: AZ174/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No