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Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension

ConditionsPulmonary HypertensionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Giessen

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Inpatients aged ≥18 years

Undergoing right heart catheterization (RHC)

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention is planned as part of the study

    Other intervention

    No intervention is planned as part of the study

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Pulmonary hypertension1 intervention
Group B: No pulmonary hypertension1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Giessen

Lead sponsor

Icahn School of Medicine at Mount Sinai

Collaborator

University of Virginia

Collaborator

Kerckhoff Klinik

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Source ClinicalTrials.gov
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