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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| strict volume control policy | Active Comparator | strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied. |
|
| antihypertensive drugs administration | Other | antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| strict volume control policy | Procedure | strict volume control by UF and dietary salt restriction |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan Ok, M.D | Ege University School of Medicine Nephrology Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adana Numune Research and Education Hospital | Adana | Adana | 01100 | Turkey (Türkiye) | ||
| Ege University School of Medicine Division of Nephrology |
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| antihypertensive drugs administration | Procedure | continue antihypertensive medications |
|
| Bornova |
| İzmir |
| 35100 |
| Turkey (Türkiye) |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| D002318 | Cardiovascular Diseases |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
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