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The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.
Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:
The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active AVF | Patients after kidney transplantation with functioning AVF |
| |
| No AVF | Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| presence of AVF | Other | Functioning AVF may have cardiotoxic potential |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life with EQ-5D-5L | The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life. | Baseline visit up to 12 months |
| Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1) | The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated. | Baseline visit and up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization-free survival | Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization. | Up to 12 months from baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Letachowicz, MD, PhD | Contact | +48717332546 | krzysztof.letachowicz@umed.wroc.pl |
| Name | Affiliation | Role |
|---|---|---|
| Krzysztof Letachowicz, MD, PhD | Wroclaw Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology and Transplantation Medicine | Recruiting | Wroclaw | 55-556 | Poland |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Blood
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |