Kidney Transplantation and Renal and Myocardial Perfusion

NCT02960802 | Unknown DMC

• 1 other identifier: T257/2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The cardiovascular morbidity and mortality is significantly higher in chronic kidney disease (CKD) patients, especially in dialysis patients, than in normal population. The increased risk of cardiovascular diseases is multifactorial.Endothelial dysfunction is one of the explanations for the poor outcome of kidney patients. The kidney transplantation seems to halt the progression of the cardiovascular morbidity. Coronary flow reserve (CFR), the capacity of coronary vessels to dilate in response to vasoactive agent, is a marker of the endothelial dysfunction. It is reduced in renal impairment as well as in many preatherosclerotic states and coronary heart disease. The method of choice to evaluate CRF is positron emission tomography (PET). In kidney transplant patients CFR seems to be worse than in healthy controls but better than in dialysis patients. However, the evidence is scarce. Renal flow reserve (RFR) is smaller than that of heart. RFR probably reflects endothelial function in the same way as CFR does. Declining RFR could perhaps be used to anticipate worsening kidney function especially in kidney transplant patients and be in favour for transplant biopsy.There are no studies of RFR in renal allograft patients. The objectives of this study are to examine the effect of kidney transplantation on coronary flow reserve (CFR), the change of renal flow reserve (RFR) in kidney transplant patients during the first year after transplantation and assess the correlation between the change of renal blood flow / RFR and kidney biopsy findings in kidney transplant patients. The first hypothesis of this study is that coronary flow reserve of transplant patients is better than that of dialysis patients but worse than that of healthy controls. The second hypothesis is that renal transplant perfusion reserve is better at one year than at three months after transplantation. The third hypothesis is that pathologic kidney biopsy findings correlate negatively with renal perfusion reserve.

Conditions

Kidney Transplant Failure

Keywords

kidney transplant; renal blood flow

Outcome Measures

Primary Outcomes (2)

• renal flow reserve of kidney transplant patients

  renal flow reserve of kidney transplant patients is measured by PET-camera at 3 months and at one year after transplantation, unit is ml/ml (blood/renal tissue)

  one year

• cardiac flow reserve of kidney transplant patients

  cardiac flow reserve is measured by PET-camera during dialysis time and at one year after transplantation, unit is ml/g

  supposed to be 1-3 years depending how quickly patient gets the transplant

Secondary Outcomes (1)

• the difference of cardiac flow reserve of kidney transplant patients who have been previously peritoneal dialysis or hemodialysis patients

  supposed to be 1-3 years depending how quickly patient gets the transplant

Study Arms (2)

kidney transplant patient

ACTIVE COMPARATOR

kidney transplantation is intervention

Procedure: kidney transplantation

healthy control

NO INTERVENTION

no intervention

Interventions

kidney transplantation PROCEDURE

Also known as: transplant

kidney transplant patient

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dialysis patients who are on the kidney waiting list

You may not qualify if:

• diabetes, hypertension, coronary artery disease, cerebrovascular disease, universal atherosclerosis
• kidney transplant is 3+/-1years old
• manifest coronary artery disease, cerebrovascular disease, universal atherosclerosis

Sponsors & Collaborators

• Turku University Hospital: lead

Related Publications (15)

• Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.

  PMID: 15385656 RESULT

• Culleton BF, Larson MG, Wilson PW, Evans JC, Parfrey PS, Levy D. Cardiovascular disease and mortality in a community-based cohort with mild renal insufficiency. Kidney Int. 1999 Dec;56(6):2214-9. doi: 10.1046/j.1523-1755.1999.00773.x.

  PMID: 10594797 RESULT

• Morris ST, McMurray JJ, Rodger RS, Jardine AG. Impaired endothelium-dependent vasodilatation in uraemia. Nephrol Dial Transplant. 2000 Aug;15(8):1194-200. doi: 10.1093/ndt/15.8.1194.

  PMID: 10910444 RESULT

• Al-Mallah MH, Hachamovitch R, Dorbala S, Di Carli MF. Incremental prognostic value of myocardial perfusion imaging in patients referred to stress single-photon emission computed tomography with renal dysfunction. Circ Cardiovasc Imaging. 2009 Nov;2(6):429-36. doi: 10.1161/CIRCIMAGING.108.831164. Epub 2009 Sep 8.

  PMID: 19920040 RESULT

• Jerosch-Herold M, Wilke N, Stillman AE. Magnetic resonance quantification of the myocardial perfusion reserve with a Fermi function model for constrained deconvolution. Med Phys. 1998 Jan;25(1):73-84. doi: 10.1118/1.598163.

  PMID: 9472829 RESULT

• Dries DL, Exner DV, Domanski MJ, Greenberg B, Stevenson LW. The prognostic implications of renal insufficiency in asymptomatic and symptomatic patients with left ventricular systolic dysfunction. J Am Coll Cardiol. 2000 Mar 1;35(3):681-9. doi: 10.1016/s0735-1097(99)00608-7.

  PMID: 10716471 RESULT

• Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6. doi: 10.1038/327524a0.

  PMID: 3495737 RESULT

• Green MA, Hutchins GD. Positron emission tomography (PET) assessment of renal perfusion. Semin Nephrol. 2011 May;31(3):291-9. doi: 10.1016/j.semnephrol.2011.05.008.

  PMID: 21784278 RESULT

• Koivuviita N, Liukko K, Kudomi N, Oikonen V, Tertti R, Manner I, Vahlberg T, Nuutila P, Metsarinne K. The effect of revascularization of renal artery stenosis on renal perfusion in patients with atherosclerotic renovascular disease. Nephrol Dial Transplant. 2012 Oct;27(10):3843-8. doi: 10.1093/ndt/gfs301. Epub 2012 Jul 10.

  PMID: 22785108 RESULT

• Alpert NM, Rabito CA, Correia DJ, Babich JW, Littman BH, Tompkins RG, Rubin NT, Rubin RH, Fischman AJ. Mapping of local renal blood flow with PET and H(2)(15)O. J Nucl Med. 2002 Apr;43(4):470-5.

  PMID: 11937589 RESULT

• Beregi JP, Lahoche A, Willoteaux S, McFadden E, Bordet R, Gautier C, Etchrivi T. Renal artery vasomotion: in vivo assessment in the pig with intravascular Doppler. Fundam Clin Pharmacol. 1998;12(6):613-8. doi: 10.1111/j.1472-8206.1998.tb00994.x.

  PMID: 9818293 RESULT

• Hollenberg NK, Sandor T. Vasomotion of renal blood flow in essential hypertension. Oscillations in xenon transit. Hypertension. 1984 Jul-Aug;6(4):579-85. doi: 10.1161/01.hyp.6.4.579.

  PMID: 6746087 RESULT

• Manoharan G, Pijls NH, Lameire N, Verhamme K, Heyndrickx GR, Barbato E, Wijns W, Madaric J, Tielbeele X, Bartunek J, De Bruyne B. Assessment of renal flow and flow reserve in humans. J Am Coll Cardiol. 2006 Feb 7;47(3):620-5. doi: 10.1016/j.jacc.2005.08.071. Epub 2006 Jan 18.

  PMID: 16458147 RESULT

• Juillard L, Janier MF, Fouque D, Cinotti L, Maakel N, Le Bars D, Barthez PY, Pozet N, Laville M. Dynamic renal blood flow measurement by positron emission tomography in patients with CRF. Am J Kidney Dis. 2002 Nov;40(5):947-54. doi: 10.1053/ajkd.2002.36325.

  PMID: 12407639 RESULT

• Bosmans JL, Ysebaert DK, Verpooten GA. Chronic allograft nephropathy: what have we learned from protocol biopsies? Transplantation. 2008 Apr 15;85(7 Suppl):S38-41. doi: 10.1097/TP.0b013e318169c5d0.

  PMID: 18401262 RESULT

Related Links

• N Engl J Med. 2004 Sep 23;351(13):1296-305
• Kidney Int. 1999 Dec;56(6):2214-9.
• Nephrol Dial Transplant. 2000 Aug;15(8):1194-200.
• Circ Cardiovasc Imaging. 2009 Nov;2(6):429-36
• Med Phys. 1998 Jan;25(1):73-84
• J Am Coll Cardiol. 2000 Mar 1;35(3):681-9
• Nature. 1987 Jun 11-17;327(6122):524-6.
• Semin Nephrol. 2011 May;31(3):291-9
• Nephrol Dial Transplant. 2012 Oct;27(10):3843-8
• J Nucl Med. 2002 Apr;43(4):470-5.
• Fundam Clin Pharmacol. 1998;12(6):613-8.
• Hypertension. 1984 Jul-Aug;6(4):579-85
• J Am Coll Cardiol. 2006 Feb 7;47(3):620-5.
• Am J Kidney Dis. 2002 Nov;40(5):947-54.
• Transplantation. 2008 Apr 15;85(7 Suppl):S38-41

MeSH Terms

Interventions

Kidney Transplantation; Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Johanna Päivärinta, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 1, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share