Status:
COMPLETED
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
University of Bologna
Conditions:
Mortality
Hyperhomocysteinemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomized prospective study was done to determine whether i.v. 5-methyltetrahydrofolate vs oral folate improved survival in ESRD patients. Homocysteine, CRP, Lp(a), albumin, folates, vitamin B6 and...
Detailed Description
BACKGROUND Hemodialysis patients show a 20-fold increase in CVD mortality in comparison to the general population. Although hyperhomocysteinemia has been implicated as an important independent risk f...
Eligibility Criteria
Inclusion
- Hemodialysis patients with age \> 18 years on regular bicarbonate hemodialysis or hemodiafiltration treatment three times a week
- Clinical stability at least three months before the study started
- Cardiovascular disease assessment as presence/absence of hypertension, ischemic cardiac disease, cerebral and peripheral vascular disease, diabetes.
- We will investigate coronary artery disease by determination of at least one of the following parameters:
- previous documentation of acute myocardial infarction (laboratory or ECG modifications);
- symptomatic CVD events in the clinical history confirmed by a positive treadmill test;
- coronary artery stenosis more than 50% in one of the three major coronary vessels documented by an angiographic study. All patients with coronary artery disease will be examined by a treadmill test (thallium scan) or coronary angiographic exam before entering the study.
- We will investigate cerebrovascular disease by one of the following criteria:
- a previous ictus (ongoing clinical evidence of neurological deficit in the three months before the study beginning, confirmed by a TC scan, a nuclear magnetic resonance or a physician's record of clinical history);
- carotid vessels stenosis more than 50% documented by a Doppler exam.
- Peripheral vascular disease will be assessed by the evidence of claudication intermittence, previous vascular surgical procedure (including amputation for ischemic limb or by angiographic/Doppler documentation of atherosclerotic plaques in abdominal, iliac and femoral vessels). The vascular surgical procedure will be carried out at least three months before the study started.
Exclusion
- Diagnosis of one of the following clinical conditions in the last three months:
- acute infection
- vascular access thrombosis
- ictus cerebri
- myocardial infarction
- hemorrhage
- recent relevant surgery
- Malignancy
- Participation in other clinical trials
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00626223
Start Date
January 1 1998
End Date
July 1 2007
Last Update
March 18 2021
Active Locations (1)
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1
Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital
Bologna, Italy, 40138