Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00307463|
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease||Procedure: strict volume control policy Procedure: antihypertensive drugs administration||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
Active Comparator: strict volume control policy
strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
Procedure: strict volume control policy
strict volume control by UF and dietary salt restriction
antihypertensive drugs administration
antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.
Procedure: antihypertensive drugs administration
continue antihypertensive medications
- regression of left ventricular hypertrophy [ Time Frame: one year ]
- regression of left ventricular mass [ Time Frame: one year ]
- change in left ventricular end-diastolic volume [ Time Frame: one year ]
- change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307463
|Ege University School of Medicine Division of Nephrology|
|Bornova, Izmir, Turkey, 35100|
|Adana Numune Research and Education Hospital|
|Adana, Turkey, 01100|
|Study Chair:||Ercan Ok, M.D||Ege University School of Medicine Nephrology Department|