NCT00307463

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
PROCEDURE	strict volume control policy	strict volume control by UF and dietary salt restriction
PROCEDURE	antihypertensive drugs administration	continue antihypertensive medications

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2006-03-28
• Last updated: 2013-09-09

Locations

2 sites across 1 country: Turkey (Türkiye)