Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

NCT ID: NCT04842591

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-23

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Hypertension Kidney Transplantation Haemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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kidney transplant candidates

Patients listed for first kidney transplantation

exercise echocardiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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exercise echocardiography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabor Kovacs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 26318161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30545968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17568785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9820470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18586172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28660793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16775448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23548763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23739239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22530005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23438072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32199709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29697854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28735990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20299337 (View on PubMed)

Tang M, Batty JA, Lin C, Fan X, Chan KE, Kalim S. Pulmonary Hypertension, Mortality, and Cardiovascular Disease in CKD and ESRD Patients: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2018 Jul;72(1):75-83. doi: 10.1053/j.ajkd.2017.11.018. Epub 2018 Feb 9.

Reference Type BACKGROUND
PMID: 29429751 (View on PubMed)

Other Identifiers

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33-022 ex 20/21

Identifier Type: -

Identifier Source: org_study_id

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