Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation; Pulmonary Hypertension; Haemodialysis
• Intervention / Treatment: Diagnostic test: exercise echocardiography

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Gabor Kovacs, MD; Phone Number: +43-316-385-80748; Email: gabor.kovacs@klinikum-graz.at
• Study Contact Backup: Name: Balazs Odler, MD, PhD; Email: balazs.odler@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
    • Contact: Gabor Kovacs, MD; Phone Number: +43-316-385-80748; Email: gabor.kovacs@klinikum-graz.at
    • Contact: Balazs Odler, MD, PhD; Phone Number: +43-316-385-81309; Email: balazs.odler@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients listed for kidney transplantation.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
kidney transplant candidates; Patients listed for first kidney transplantation	Diagnostic test: exercise echocardiography; All patients will undergo exercise echocardiography during a symptom-limited cardiopulmonary exercise test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 1 year after kidney transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Janssen-Cilag G.m.b.H
• Investigators: Principal Investigator: Gabor Kovacs, MD, PhD, Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Eur Respir J. 2015 Dec;46(6):1855-6.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: echocardiography; kidney transplantation; pulmonary hypertension; vascular remodeling; pulmo-renal axis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 33-022 ex 20/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No