End-stage Renal Disease Clinical Trial
Official title:
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
This study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume control (by strict dietary salt restriction and persistent ultrafiltration) without using antihypertensive drugs on cardiac structure and inflammation.
This randomised, controlled and prospective study aims mainly to investigate the effects of
two approaches to control blood pressure in hypertensive hemodialysis patients; using
antihypertensive drugs versus persistent strict volume control without using
antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and
inflammation.
We hypothesize that better blood pressure control and regression of left ventricular mass
may be reached by a policy of strict volume control consisting of strict dietary salt
restriction and persistent ultrafiltration.
258 Hypertensive hemodialysis patients (BP>130/80 mmHg and/or being on antihypertensive
medication) will be randomized to two arms:
Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be
applied.
Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both
groups.
The patients will be evaluated at 12 months for primary outcomes. Primary end-points are
significant changes in left ventricular hypertrophy and left ventricular mass and
significant change in left ventricular end-diastolic volume.
Secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin,
BNP and hsCRP levels.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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