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Completed

NCT Number: NCT00307463

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strict volume control policy

Procedure

strict volume control by UF and dietary salt restriction

antihypertensive drugs administration

Procedure

continue antihypertensive medications

Primary outcomes

  1. regression of left ventricular hypertrophy

    Time frame: one year

  2. regression of left ventricular mass

    Time frame: one year

  3. change in left ventricular end-diastolic volume

    Time frame: one year

Secondary outcomes

  1. change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 28, 2006
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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