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Assessment of the impact of nephrectomy on cardiovascular risk in living kidney donors: longitudinal follow-up. Focus on endothelial dysfunction, inflammation and oxidative stress.

Assessment of the impact of nephrectomy on cardiovascular risk in living kidney donors: longitudinal follow-up. Focus on endothelial dysfunction, inflammation and oxidative stress.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000141044
Enrollment
120
Registered
2010-02-11
Start date
2007-08-23
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess the impact of nephrectomy on cardiovascular risk factors and vascular function, with emphasis on early markers of vasuclar disease including endothelial dysfunction, oxidative stress and inflammation. The follow-up studies of donor safety are flawed by being retrospective and with significant loss to follow-up. The numbers of patients who have died or have significant cardiovascular disease have not been adequately assessed. In the general population any degree of renal impairment, eGFR < 60mls/min (Glomerular filtration rate) is independently associated with an increase in cardiovascular risk, death and hospitalization. Retrospective analysis or our cohort of live donors over the last 15 years (up till 2005) revealed that 39% of respondents had stage 2 (eGFR 15 -30mls/min) chronic kidney disease. We hypothesize that donors, post nephrectomy with the associated decrement in GFR may be at increased risk of future vascular disease. Specifically, we will scrutinize the following features of early vascular disease: Inflammation: hsC-reactive protein, IL-6 Endothelial dysfunction: Brachial Artery Reactivity ) Smooth muscle dysfunction: Pulse Wave Velocity Oxidative stress:Plasma, urinary 8-iso-prostaglandin 2 and oxidized LDL Vascular structure: Carotid intima-media thickness We will also collect data relevant to features of metabolic syndrome including triglyceride, High Density Lipoprotein, waist-hip ratio and fasting glucose, to determine the association between renal and cardiac function and traditional cardiovascular risk factors. This is a 5 year longituidinal study of live donors. All patients will be reviewed in outpatient clinic every 12 months. Data on vascular imaging studies will be collected at baseline and annually. Glomerular filtration rate will be estimated at baseline and annually using 24 hour urine collection, MDRD and 51Cr-EDTA nuclear scan. 24 hour urine collection will be used to measure urinary protein and albumin excretion. All cardiovascular events, admissions, biochemical and clinical data will be recorded at specific annually at time of follow up. A control group (already established within the CCRE), matched for age and gender will be approached for comparative purposes.

Interventions

The aim of this study is to assess the impact of nephrectomy on cardiovascular risk factors and vascular function, with emphasis on early markers of vasuclar disease including endothelial dysfunction, oxidative stress and inflammation. Specifically, we will scrutinize the following features of early vascular disease: Inflammation: hsC-reactive protein, Interleukin-6 (IL-6) Endothelial dysfunction: Brachial Artery Reactivity Smooth muscle dysfunction: Pulse Wave Velocity Oxidative stress:Pla

The aim of this study is to assess the impact of nephrectomy on cardiovascular risk factors and vascular function, with emphasis on early markers of vasuclar disease including endothelial dysfunction, oxidative stress and inflammation. Specifically, we will scrutinize the following features of early vascular disease: Inflammation: hsC-reactive protein, Interleukin-6 (IL-6) Endothelial dysfunction: Brachial Artery Reactivity Smooth muscle dysfunction: Pulse Wave Velocity Oxidative stress:Plasma, urinary 8-iso-prostaglandin 2 and oxidized low density lipoprotein (LDL) Vascular structure: Carotid intima-media thickness We will also collect data relevant to features of metabolic syndrome including triglyceride, High Density Lipoprotein, waist-hip ratio and fasting glucose, to determine the association between renal and cardiac function and traditional cardiovascular risk factors. All patients will be reviewed in outpatient clinic every 12 months for a total of 5 years. Data on vascular imaging studies will be collected at baseline and annually. Glomerular filtration rate will be estimated at baseline and annually using 24 hour urine collection, Modification of renal diet (MDRD) and 51Cr-Chromium-51 Ethylenediamine Tetraacetic acid (EDTA) nuclear scan. 24 hour urine collection will be used to measure urinary protein and albumin excretion. All cardiovascular events, admissions, biochemical and clinical data will be recorded at specific annually at time of follow up.

Sponsors

University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Patients who fulfill the live donation selection process and successfully complete donor nephrectomy

Exclusion criteria

Patients from areas in Queensland where follow up vascular studies can not be carried out for logistic reasons.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026