1. To assess whether nocturnal hemodialysis and renal transplantation give less progression of arterial calcification, compared with conventional hemodialysis and peritoneal dialysis;2. To identify the risk factors for arterial calcification in…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Nephropathies
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- individual change in coronary artery calcification score
Secondary outcome
- individual change in pulse wave velocity
- change in in calcification score in aorta and iliac arteries
- change in coronary stenosis and left ventricular function
- association between calciumphosphate homeostasis, inflammatory parameters and
calcification inhibitors on the one hand and change in coronary artery
calcification score on the other hand
Background summary
Cardiovascular disease is the leading cause of mortality in patients with
end-stage renal disease (ESRD). The vascular abnormalities in ESRD are
especially characterized by arterial wall calcifications, whereas intimal
hyperplasia seen with *classic atherosclerosis* is less pronounced. These
calcifications are strongly associated with increased mortality. The exact
mechanism by which calcification develops is unknown, but there is a direct
relationship with increased serum calcium and serum phosphorus. With long and
frequent hemodialysis, such as nocturnal hemodialysis, and with renal
transplantation, calcium and phosphate values can be normalized. It is unknown
whether these treatments inhibit the progression of arterial calcification or
bring about regression of calcification. The hypothesis of this study is that
with nocturnal hemodialysis the progression of arterial calcification is less
than with conventional hemo- or peritoneal dialysis, and approximates the
progression rate seen with a renal transplant.
Study objective
1. To assess whether nocturnal hemodialysis and renal transplantation give less
progression of arterial calcification, compared with conventional hemodialysis
and peritoneal dialysis;
2. To identify the risk factors for arterial calcification in dialysis and
transplant patients.
Study design
Prospective observational cohort study, comparing 4 cohorts with a follow-up of
3 years; each cohort exists of 40 patients to account for a 25%
lost-to-follow-up-rate (e.g. by renal transplantation in the 3 dialysis groups,
or by mortality).
Study burden and risks
- The study is an observational study, not an intervention-study.
- Participation does not influence or change the nature of the treatment, i.c.
the modality of renal replacement therapy;
- Participation is associated with limited physical examination, questionnaires
and blood sampling;
- Blood sampling is performed in combination with regular blood sampling, and
requires a maximum of 10 cc blood per visit extra, twice a year;
- Multislice-CT-scan is performed at inclusion, and after 1, 2 and 3 years;
this scan takes < 1 minute of time and radiation exposure is less than with
conventional abdominal CT-scan;
- Yearly measurements of pulse-wave velocity are done with ultrasound
(non-invasive), which takes 30 minutes of time.
Brennerbaan 130
Utrecht 3524 BN
NL
Brennerbaan 130
Utrecht 3524 BN
NL
Listed location countries
Age
Inclusion criteria
1. patients who start with nocturnal home hemodialysis
2. patients who undergo an renal transplant from a living donor
3. patients treated with conventional hemodialysis
4. patients treated with peritoneal dialysis
NB patients aged 18-80 yr are included
Exclusion criteria
- life expectancy < 3 months
- claustrophobia
- allergy to iodinated contrast
- treatment incompliance, i.e. non-adherence to dialysis regimens and drug use
- GFR < 30 ml/min (according to MDRD formula) in renal transplant patients
- pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT00950573 |
CCMO | NL18314.041.08 |