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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Procedure: strict volume control policy
* Procedure: antihypertensive drugs administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: strict volume control policy<br>strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied. | Procedure: strict volume control policy<br>* strict volume control by UF and dietary salt restriction<br>|
| Other: antihypertensive drugs administration<br>antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups. | Procedure: antihypertensive drugs administration<br>* continue antihypertensive medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal disease, hemodialysis, volume control, ultrafiltration, inflammation, cardiovascular disease, left ventricular hypertrophy, dietary salt restriction