Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation

Condition(s) targeted: End-Stage Renal Disease; Hemodialysis

Intervention: strict volume control (Procedure); antihypertensive medications (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Ege University

Official(s) and/or principal investigator(s):
Ercan Ok, M.D, Study Chair, Affiliation: Ege University School of Medicine Nephrology Department

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.

Official title: Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

regression of left ventricular hypertrophy

regression of left ventricular mass

change in left ventricular end-diastolic volume

Secondary outcome: change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: aged between 18-70 years old on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week willingness to participate in the study with a written informed consent. Exclusion Criteria: to be scheduled for living donor renal transplantation to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating

Adana Numune Research and Education Hospital, Adana 01100, Turkey

Ege University School of Medicine Division of Nephrology, Bornova, Izmir 35100, Turkey

Starting date: September 2005
Ending date: September 2006
Last updated: December 20, 2007