Inflammation Clinical Trial
Official title:
Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis
The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).
Once included, patients will be randomly allocated (by a computer-generated randomization
list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan,
group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets
during a period of 3 months. All patients will have 3 HD sessions per week, with the same
kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for
clinical and biochemical evaluations. A blood sample will be taken at baseline and every
month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids,
and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor
necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by
ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive
protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits.
All laboratory measurements, including inflammation markers, will be performed in the Central
Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same
personnel blinded to patient's details.
Treatment compliance will be recorded by counting tablets left in the container at the end of
each monthly visit.
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