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

Phase 4

Completed

• Conditions: End-stage Renal Disease
• Interventions: Procedure: strict volume control policy; Procedure: antihypertensive drugs administration

• Registration Number: NCT00307463
• Lead Sponsor: Ege University

Brief 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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
strict volume control policy	strict volume control policy	strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
antihypertensive drugs administration	antihypertensive drugs administration	antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

Primary Outcome Measures

Name	Time	Method
regression of left ventricular hypertrophy	one year
regression of left ventricular mass	one year
change in left ventricular end-diastolic volume	one year

Secondary Outcome Measures

Name	Time	Method
change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels	one year

Trial Locations

Locations (2)

Adana Numune Research and Education Hospital; 🇹🇷 Adana, Turkey

Ege University School of Medicine Division of Nephrology; 🇹🇷 Bornova, Izmir, Turkey