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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307463

Enrollment

258

Registered

2006-03-28

Start date

2005-09-30

Completion date

2006-09-30

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

Keywords

end-stage renal disease, hemodialysis, volume control, ultrafiltration, inflammation, cardiovascular disease, left ventricular hypertrophy, dietary salt restriction

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.

Interventions

PROCEDUREstrict volume control policy

strict volume control by UF and dietary salt restriction

PROCEDUREantihypertensive drugs administration

continue antihypertensive medications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
regression of left ventricular hypertrophy	one year
regression of left ventricular mass	one year
change in left ventricular end-diastolic volume	one year

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026