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RecruitingNCT06409624Updated Sep 8, 2026

Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

An observational study in Pulmonary Hypertension and Chronic Kidney Disease, sponsored by University of Giessen. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Giessen · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Pulmonary Hypertension
  • Chronic Kidney Disease
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 400 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University of Giessen is the lead sponsor of 91 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherNo intervention is planned as part of the study

    No intervention is planned as part of the study

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline to 12 months

  2. 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

    Time frame: Baseline to 12 months

Secondary outcomes

  1. All-cause mortality

    Number of patients experiencing all-cause mortality during follow-up

    Time frame: Baseline to 12 months

  2. Kidney function decline

    Number of patients with 50% decline in eGFR from baseline and the eGFR slope at 12 months

    Time frame: 12 months

  3. Pulmonary hypertension-related death

    Death attributed to pulmonary hypertension

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
  • 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
08

References and documents

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. PubMed 37664568 ↗
  • 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. PubMed 29174533 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06409624
Lead sponsor
University of Giessen
Collaborators
Icahn School of Medicine at Mount Sinai, University of Virginia, Kerckhoff Klinik, Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
May 10, 2024
Start date
May 31, 2024
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Faeq Husain-Syed, MD
Contact
faeq.husain-syed@innere.med.uni-giessen.de
+49 641 985 42378
Birgit Jennert, MLA
Contact
birgit.jennert@innere.med.uni-giessen.de
+49 641 985 42378
Faeq Husain-Syed, MD
principal investigator · University of Giessen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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