Kidney Transplantation and Renal and Myocardial Perfusion (Transkidney)
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|ClinicalTrials.gov Identifier: NCT02960802|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : September 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Failure||Procedure: kidney transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kidney Transplantation and Renal and Myocardial Perfusion|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 2022|
Active Comparator: kidney transplant patient
kidney transplantation is intervention
Procedure: kidney transplantation
Other Name: transplant
No Intervention: healthy control
- renal flow reserve of kidney transplant patients [ Time Frame: one year ]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)
- cardiac flow reserve of kidney transplant patients [ Time Frame: supposed to be 1-3 years depending how quickly patient gets the transplant ]cardiac flow reserve is measured by PET-camera during dialysis time and at one year after transplantation, unit is ml/g
- the difference of cardiac flow reserve of kidney transplant patients who have been previously peritoneal dialysis or hemodialysis patients [ Time Frame: supposed to be 1-3 years depending how quickly patient gets the transplant ]the cardiac flow reserve is measured by PET during dialysis and at one year after kidney transplantation, unit is ml/g
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960802
|Principal Investigator:||Johanna Päivärinta, MD||Turku University Hospital|