Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

NCT06409624 | Recruiting DMC

• 1 other identifier: AZ174/18
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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).

Conditions

Pulmonary Hypertension; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Major adverse kidney events

  Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or kidney-related death

  Baseline to 12 months

• Worsening PH or HF

  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

  Baseline to 12 months

Secondary Outcomes (3)

• All-cause mortality

  Baseline to 12 months

• Kidney function decline

  12 months

• Pulmonary hypertension-related death

  12 months

Study Arms (2)

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 pulmonary hypertension

Patients in whom PH was excluded by right heart catheterization

Other: No intervention is planned as part of the study

Interventions

No intervention is planned as part of the study OTHER

No intervention is planned as part of the study

No pulmonary hypertension; Pulmonary hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead
• Kerckhoff Klinik: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Virginia: collaborator

Study Sites (2)

Kerckhoff Klinik Heart and Thorax Center

Bad Nauheim, Hesse, Germany

RECRUITING

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

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 37664568 BACKGROUND

• 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.

  PMID: 29174533 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood samples.

MeSH Terms

Conditions

Hypertension, Pulmonary; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Faeq Husain-Syed, MD

  University of Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faeq Husain-Syed, MD

CONTACT

+49 641 985 42378; faeq.husain-syed@innere.med.uni-giessen.de

Birgit Jennert, MLA

CONTACT

+49 641 985 42378; birgit.jennert@innere.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

DE (2)