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Sponsored by: |
Ege University |
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Information provided by: | Ege University |
ClinicalTrials.gov Identifier: | NCT00307463 |
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.
Condition | Intervention | Phase |
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End-Stage Renal Disease Hemodialysis |
Procedure: strict volume control Procedure: antihypertensive medications |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study |
Enrollment: | 258 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
strict volume control policy
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Procedure: strict volume control
strict volume control by UF and dietary salt restriction
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2
antihypertensive drugs administration
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Procedure: antihypertensive medications
continue antihypertensive medications
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Adana Numune Research and Education Hospital | |
Adana, Turkey, 01100 | |
Turkey, Izmir | |
Ege University School of Medicine Division of Nephrology | |
Bornova, Izmir, Turkey, 35100 |
Study Chair: | Ercan Ok, M.D | Ege University School of Medicine Nephrology Department |
Responsible Party: | Ege University ( Ege University ) |
Study ID Numbers: | Ege1336 |
Study First Received: | March 27, 2006 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00307463 History of Changes |
Health Authority: | Turkey: Ministry of Health |
end-stage renal disease hemodialysis volume control ultrafiltration |
inflammation cardiovascular disease left ventricular hypertrophy dietary salt restriction |
Hypertrophy, Left Ventricular Renal Insufficiency Hypertrophy Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Cardiovascular Agents Kidney Diseases Antihypertensive Agents Kidney Failure Inflammation |
Renal Insufficiency Pathologic Processes Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Kidney Failure, Chronic |
Cardiovascular Agents Kidney Diseases Antihypertensive Agents Pharmacologic Actions Kidney Failure Inflammation |