Association Between Biomarkers and eGFR Decline in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06409624
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Giessen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Faeq Husain-Syed, MD
Principal Investigator Affiliation University of Giessen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension
Additional Details

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.

Arms & Interventions

Arms

: Pulmonary hypertension

Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment

: No pulmonary hypertension

Patients in whom PH was excluded by right heart catheterization

Interventions

Other: - No intervention is planned as part of the study

No intervention is planned as part of the study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Giessen, Hessen, Germany

Status

Recruiting

Address

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

Giessen, Hessen, 35392

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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