Clinical trial NCT04842591: Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation
Official title: Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Hypertension
Kidney Transplantation
Haemodialysis
Keywords: pulmonary hypertension
kidney transplantation
vascular remodeling
echocardiography
pulmo-renal axis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag G.m.b.H
First posted: 2021-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients listed for kidney transplantation.

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope
timeFrame: Baseline and 1 year after kidney transplantation
Secondary outcomes:
measure: Change in systolic pulmonary arterial pressure at rest before versus one year after kidney transplantation assessed by (exercise) echocardiography
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in systolic pulmonary arterial pressure at 25 Watts before versus one year after kidney transplantation assessed by (exercise) echocardiography
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in mean pulmonary arterial pressure at rest before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in mean pulmonary arterial pressure during exercise before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in pulmonary vascular resistance at rest before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in pulmonary vascular resistance during exercise before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in pulmonary arterial wedge pressure at rest before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in pulmonary arterial wedge pressure during exercise before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in cardiac output at rest before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
measure: Change in cardiac output during exercise before versus one year after kidney transplantation
timeFrame: Baseline and 1 year after kidney transplantation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
Study officials:
affiliation: Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
name: Gabor Kovacs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.