Pulmonary HypertensionNCT04842591

Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

An observational study of Pulmonary Hypertension and Kidney Transplantation, run by Medical University of Graz at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Hypertension, Kidney Transplantation, Haemodialysis
What is being tested?: exercise echocardiography
How many people: 60 participants
Where: 1 siteAustria
Study dates: 23 Dec 2020to 31 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
No healthy volunteers
Adult, Older adult

Study population: Patients listed for kidney transplantation.

Who may be able to join

Age: ≥ 18 years
patients listed for first kidney transplantation at the Clinical Division of Nephrology

Who cannot join

Age < 18 years
combined organ transplantations (heart-kidney, pancreas-kidney etc.)
patients with prior kidney transplantation
high calcium score on cardiac-CT (> 160 Agatston Score)

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
Graz, 8036

Other trials in Austria

About this study

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.

Conditions: Pulmonary Hypertension, Kidney Transplantation, Haemodialysis
Being tested: exercise echocardiography
Keywords: pulmonary hypertension, kidney transplantation, vascular remodeling, echocardiography, pulmo-renal axis
Medical subject headings: Hypertension, Pulmonary, Vascular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exercise echocardiographyDiagnostic test
All patients will undergo exercise echocardiography during a symptom-limited cardiopulmonary exercise test.

Study groups in NCT04842591
Study group	Role	What they receive
kidney transplant candidates		Patients listed for first kidney transplantation Receives: Diagnostic Test: exercise echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope
Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope (calculated as the difference of maximal and resting SPAP divided by the difference of maximal and resting CO) before versus one year after kidney transplantation assessed by exercise echocardiography
Measured: Baseline and 1 year after kidney transplantation

Secondary outcomes (10)

Change in systolic pulmonary arterial pressure at rest before versus one year after kidney transplantation assessed by (exercise) echocardiography
Measured: Baseline and 1 year after kidney transplantation
Change in systolic pulmonary arterial pressure at 25 Watts before versus one year after kidney transplantation assessed by (exercise) echocardiography
Measured: Baseline and 1 year after kidney transplantation
Change in mean pulmonary arterial pressure at rest before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in mean pulmonary arterial pressure during exercise before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in pulmonary vascular resistance at rest before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in pulmonary vascular resistance during exercise before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in pulmonary arterial wedge pressure at rest before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in pulmonary arterial wedge pressure during exercise before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in cardiac output at rest before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation
Change in cardiac output during exercise before versus one year after kidney transplantation
Measured: Baseline and 1 year after kidney transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Dec 202031 Dec 2027

First posted13 Apr 2021
Study start23 Dec 2020
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
More trials run by Medical University of GrazThe sponsor's other registered studies.
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: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04842591
Sponsor's protocol ID: 33-022 ex 20/21
Status last verified: Apr 2025
First submitted: 8 Apr 2021
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
PubMed 26318161
Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
PubMed 30545968
Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.
PubMed 17568785
Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32(5 Suppl 3):S112-9. doi: 10.1053/ajkd.1998.v32.pm9820470. No abstract available.
PubMed 9820470
Wen CP, Cheng TY, Tsai MK, Chang YC, Chan HT, Tsai SP, Chiang PH, Hsu CC, Sung PK, Hsu YH, Wen SF. All-cause mortality attributable to chronic kidney disease: a prospective cohort study based on 462 293 adults in Taiwan. Lancet. 2008 Jun 28;371(9631):2173-82. doi: 10.1016/S0140-6736(08)60952-6.
PubMed 18586172
O'Leary JM, Assad TR, Xu M, Birdwell KA, Farber-Eger E, Wells QS, Hemnes AR, Brittain EL. Pulmonary hypertension in patients with chronic kidney disease: invasive hemodynamic etiology and outcomes. Pulm Circ. 2017 Jul-Sep;7(3):674-683. doi: 10.1177/2045893217716108. Epub 2017 Jun 29.
PubMed 28660793
Abassi Z, Nakhoul F, Khankin E, Reisner SA, Yigla M. Pulmonary hypertension in chronic dialysis patients with arteriovenous fistula: pathogenesis and therapeutic prospective. Curr Opin Nephrol Hypertens. 2006 Jul;15(4):353-60. doi: 10.1097/01.mnh.0000232874.27846.37.
PubMed 16775448
Kawar B, Ellam T, Jackson C, Kiely DG. Pulmonary hypertension in renal disease: epidemiology, potential mechanisms and implications. Am J Nephrol. 2013;37(3):281-90. doi: 10.1159/000348804. Epub 2013 Mar 16.
PubMed 23548763
Sise ME, Courtwright AM, Channick RN. Pulmonary hypertension in patients with chronic and end-stage kidney disease. Kidney Int. 2013 Oct;84(4):682-92. doi: 10.1038/ki.2013.186. Epub 2013 Jun 5.
PubMed 23739239
Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.
PubMed 22530005
Abedini M, Sadeghi M, Naini AE, Atapour A, Golshahi J. Pulmonary hypertension among patients on dialysis and kidney transplant recipients. Ren Fail. 2013;35(4):560-5. doi: 10.3109/0886022X.2013.766567. Epub 2013 Feb 25.
PubMed 23438072
Walther CP, Nambi V, Hanania NA, Navaneethan SD. Diagnosis and Management of Pulmonary Hypertension in Patients With CKD. Am J Kidney Dis. 2020 Jun;75(6):935-945. doi: 10.1053/j.ajkd.2019.12.005. Epub 2020 Mar 19.
PubMed 32199709
Wolfe JD, Hickey GW, Althouse AD, Sharbaugh MS, Kliner DE, Mathier MA, Wu CM, Tevar AD, Soman P. Pulmonary vascular resistance determines mortality in end-stage renal disease patients with pulmonary hypertension. Clin Transplant. 2018 Jun;32(6):e13270. doi: 10.1111/ctr.13270. Epub 2018 May 15.
PubMed 29697854
Foderaro AE, Baird GL, Bazargan-Lari A, Morrissey PE, Gohh RY, Poppas A, Klinger JR, Ventetuolo CE. Echocardiographic Pulmonary Hypertension Predicts Post-transplantation Renal Allograft Failure. Transplant Proc. 2017 Jul-Aug;49(6):1256-1261. doi: 10.1016/j.transproceed.2017.01.085.
PubMed 28735990
Zlotnick DM, Axelrod DA, Chobanian MC, Friedman S, Brown J, Catherwood E, Costa SP. Non-invasive detection of pulmonary hypertension prior to renal transplantation is a predictor of increased risk for early graft dysfunction. Nephrol Dial Transplant. 2010 Sep;25(9):3090-6. doi: 10.1093/ndt/gfq141. Epub 2010 Mar 17.
PubMed 20299337

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation
ClinicalTrials.gov ID: NCT04842591
Acronym / sponsor ID: 33-022 ex 20/21
Conditions: Pulmonary Hypertension, Kidney Transplantation, Haemodialysis
Keywords: pulmonary hypertension, kidney transplantation, vascular remodeling, echocardiography, pulmo-renal axis
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Collaborators: Janssen-Cilag G.m.b.H
Study start: 23 Dec 2020 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 13 Apr 2021 (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 aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
kidney transplant candidates	–	Diagnostic Test: exercise echocardiographyPatients listed for first kidney transplantation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients listed for kidney transplantation.

Key inclusion criteria (2 listed)

Age: ≥ 18 years
patients listed for first kidney transplantation at the Clinical Division of Nephrology

Key exclusion criteria (4 listed)

Age < 18 years
combined organ transplantations (heart-kidney, pancreas-kidney etc.)
patients with prior kidney transplantation
high calcium score on cardiac-CT (> 160 Agatston Score)

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
exercise echocardiographyAll patients will undergo exercise echocardiography during a symptom-limited cardiopulmonary exercise test.	Diagnostic test	kidney transplant candidates

Primary outcome

Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope
Time frame: Baseline and 1 year after kidney transplantation
Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope (calculated as the difference of maximal and resting SPAP divided by the difference of maximal and resting CO) before versus one year after kidney transplantation assessed by exercise echocardiography

10 secondary outcomes

Change in systolic pulmonary arterial pressure at rest before versus one year after kidney transplantation assessed by (exercise) echocardiography
Time frame: Baseline and 1 year after kidney transplantation
Change in systolic pulmonary arterial pressure at 25 Watts before versus one year after kidney transplantation assessed by (exercise) echocardiography
Time frame: Baseline and 1 year after kidney transplantation
Change in mean pulmonary arterial pressure at rest before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in mean pulmonary arterial pressure during exercise before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in pulmonary vascular resistance at rest before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in pulmonary vascular resistance during exercise before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in pulmonary arterial wedge pressure at rest before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in pulmonary arterial wedge pressure during exercise before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in cardiac output at rest before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation
Change in cardiac output during exercise before versus one year after kidney transplantation
Time frame: Baseline and 1 year after kidney transplantation

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 27 Apr 2025.
Background: PubMed 26318161Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
Background: PubMed 30545968Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
Background: PubMed 17568785Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.
Background: PubMed 9820470Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32(5 Suppl 3):S112-9. doi: 10.1053/ajkd.1998.v32.pm9820470. No abstract available.
Background: PubMed 18586172Wen CP, Cheng TY, Tsai MK, Chang YC, Chan HT, Tsai SP, Chiang PH, Hsu CC, Sung PK, Hsu YH, Wen SF. All-cause mortality attributable to chronic kidney disease: a prospective cohort study based on 462 293 adults in Taiwan. Lancet. 2008 Jun 28;371(9631):2173-82. doi: 10.1016/S0140-6736(08)60952-6.
Background: PubMed 28660793O'Leary JM, Assad TR, Xu M, Birdwell KA, Farber-Eger E, Wells QS, Hemnes AR, Brittain EL. Pulmonary hypertension in patients with chronic kidney disease: invasive hemodynamic etiology and outcomes. Pulm Circ. 2017 Jul-Sep;7(3):674-683. doi: 10.1177/2045893217716108. Epub 2017 Jun 29.
Background: PubMed 16775448Abassi Z, Nakhoul F, Khankin E, Reisner SA, Yigla M. Pulmonary hypertension in chronic dialysis patients with arteriovenous fistula: pathogenesis and therapeutic prospective. Curr Opin Nephrol Hypertens. 2006 Jul;15(4):353-60. doi: 10.1097/01.mnh.0000232874.27846.37.
Background: PubMed 23548763Kawar B, Ellam T, Jackson C, Kiely DG. Pulmonary hypertension in renal disease: epidemiology, potential mechanisms and implications. Am J Nephrol. 2013;37(3):281-90. doi: 10.1159/000348804. Epub 2013 Mar 16.
Background: PubMed 23739239Sise ME, Courtwright AM, Channick RN. Pulmonary hypertension in patients with chronic and end-stage kidney disease. Kidney Int. 2013 Oct;84(4):682-92. doi: 10.1038/ki.2013.186. Epub 2013 Jun 5.
Background: PubMed 22530005Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.
Background: PubMed 23438072Abedini M, Sadeghi M, Naini AE, Atapour A, Golshahi J. Pulmonary hypertension among patients on dialysis and kidney transplant recipients. Ren Fail. 2013;35(4):560-5. doi: 10.3109/0886022X.2013.766567. Epub 2013 Feb 25.
Background: PubMed 32199709Walther CP, Nambi V, Hanania NA, Navaneethan SD. Diagnosis and Management of Pulmonary Hypertension in Patients With CKD. Am J Kidney Dis. 2020 Jun;75(6):935-945. doi: 10.1053/j.ajkd.2019.12.005. Epub 2020 Mar 19.
Individual participant dataSharing planned: Undecided

Related trials for Pulmonary Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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. This study is not recruiting at the moment.

Gabor Kovacs, MD, PhD principal investigator

Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

1 site 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 Kidney Transplantation, run by Medical University of Graz at 1 site in Austria.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope (time frame: Baseline and 1 year after kidney transplantation). 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 NCT04842591, which also lists 16 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 27 Apr 2025.