Clinical trial NCT00307463: Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
Official title: Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-stage Renal Disease
Keywords: end-stage renal disease
hemodialysis
volume control
ultrafiltration
inflammation
cardiovascular disease
left ventricular hypertrophy
dietary salt restriction
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: regression of left ventricular hypertrophy
timeFrame: one year
measure: regression of left ventricular mass
timeFrame: one year
measure: change in left ventricular end-diastolic volume
timeFrame: one year
Secondary outcomes:
measure: change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels
timeFrame: one year
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine Division of Nephrology
state: Izmir
city: Adana
country: Turkey
facility: Adana Numune Research and Education Hospital
Study officials:
affiliation: Ege University School of Medicine Nephrology Department
name: Ercan Ok, M.D
role: STUDY_CHAIR
References: