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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2006

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.

Interventions

  • Procedure: strict volume control policy
    • strict volume control by UF and dietary salt restriction
  • Procedure: antihypertensive drugs administration
    • continue antihypertensive medications

Arms, Groups and Cohorts

  • Active Comparator: strict volume control policy
    • strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
  • Other: antihypertensive drugs administration
    • antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

Clinical Trial Outcome Measures

Primary Measures

  • regression of left ventricular hypertrophy
    • Time Frame: one year
  • regression of left ventricular mass
    • Time Frame: one year
  • change in left ventricular end-diastolic volume
    • Time Frame: one year

Secondary Measures

  • change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ege University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ercan OK, professor – Ege University
  • Overall Official(s)
    • Ercan Ok, M.D, Study Chair, Ege University School of Medicine Nephrology Department

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