Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

NCT04842591 | Active Not Recruiting

• 1 other identifier: 33-022 ex 20/21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

pulmonary hypertension; kidney transplantation; vascular remodeling; echocardiography; pulmo-renal axis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (1)

kidney transplant candidates

Patients listed for first kidney transplantation

Diagnostic Test: exercise echocardiography

Interventions

exercise echocardiography DIAGNOSTIC_TEST

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

kidney transplant candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients listed for kidney transplantation.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead
• Janssen-Cilag G.m.b.H: collaborator

Study Sites (1)

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

Graz, 8036, Austria

Location

Related Publications (16)

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• 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.

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  PMID: 17568785 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 23548763 BACKGROUND

• 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.

  PMID: 23739239 BACKGROUND

• 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.

  PMID: 22530005 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 29429751 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hypertension, Pulmonary; Vascular Remodeling

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Gabor Kovacs, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: December 23, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

AU (1)