Pulmonary HypertensionNCT06409624
Association Between Biomarkers and Kidney Function Decline in Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Chronic Kidney Disease, run by University of Giessen at 2 sites in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Chronic Kidney Disease
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- 31 May 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Inpatients aged ≥18 years
- Undergoing right heart catheterization (RHC)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Kerckhoff Klinik Heart and Thorax Center
Bad Nauheim, Hesse
- Recruiting
University Hospital Giessen and Marburg, Campus Giessen, Department of Internal Medicine II
Giessen, Hesse, 35392
Faeq Husain-Syed, MD, +49 641 985 42378, faeq.husain-syed@innere.med.uni-giessen.de
Birgit Jennert, MLA, +49 641 985 42378, birgit.jennert@innere.med.uni-giessen.de
About this study
Official title: Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension
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.
- Conditions
- Pulmonary Hypertension, Chronic Kidney Disease
- Being tested
- No intervention is planned as part of the study
- Medical subject headings
- Hypertension, Pulmonary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned as part of the studyOther
No intervention is planned as part of the study
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary hypertension | Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment Receives: Other: No intervention is planned as part of the study | |
| No pulmonary hypertension | Patients in whom PH was excluded by right heart catheterization Receives: Other: No intervention is planned as part of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to 12 months
Secondary outcomes (3)
All-cause mortality
Number of patients experiencing all-cause mortality during follow-up
Measured: Baseline to 12 months
Kidney function decline
Number of patients with 50% decline in eGFR from baseline and the eGFR slope at 12 months
Measured: 12 months
Pulmonary hypertension-related death
Death attributed to pulmonary hypertension
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start31 May 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Virginia, Kerckhoff Klinik, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Faeq Husain-Syed, MD, Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409624
- Sponsor's protocol ID
- AZ174/18
- Status last verified
- Sep 2026
- First submitted
- 7 May 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 37664568Chakinala 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06409624
- Acronym / sponsor ID
- AZ174/18
- Conditions
- Pulmonary Hypertension, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Virginia, Kerckhoff Klinik, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 31 May 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary hypertension | – | Other: No intervention is planned as part of the studyPatients with diagnosed PH by right heart catheterization with or without PH-specific treatment |
| No pulmonary hypertension | – | Other: No intervention is planned as part of the studyPatients in whom PH was excluded by right heart catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Inpatients aged ≥18 years
- Undergoing right heart catheterization (RHC)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is planned as part of the studyNo intervention is planned as part of the study | Other | No pulmonary hypertension, Pulmonary hypertension |
Primary outcome
Major adverse kidney events
Time frame: Baseline to 12 months
Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or kidney-related death
Worsening PH or HF
Time frame: Baseline to 12 months
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
3 secondary outcomes
All-cause mortality
Time frame: Baseline to 12 months
Kidney function decline
Time frame: 12 months
Pulmonary hypertension-related death
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 37664568Husain-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.
- Results publication: PubMed 29174533Chakinala 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faeq Husain-Syed, MD principal investigator
University of Giessen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Chronic Kidney Disease, run by University of Giessen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faeq Husain-Syed, MD (+49 641 985 42378, faeq.husain-syed@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse kidney events (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06409624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.