- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307463
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Adana, Turkey, 01100
- Adana Numune Research and Education Hospital
-
-
Izmir
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Bornova, Izmir, Turkey, 35100
- Ege University School of Medicine Division of Nephrology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: strict volume control policy
strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
|
strict volume control by UF and dietary salt restriction
|
Other: antihypertensive drugs administration
antihypertensive drugs administration: Antihypertensive medicine will be continued.
Target BP will be 130/80 mmHg in both groups.
|
continue antihypertensive medications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
regression of left ventricular hypertrophy
Time Frame: one year
|
one year
|
regression of left ventricular mass
Time Frame: one year
|
one year
|
change in left ventricular end-diastolic volume
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ercan Ok, M.D, Ege University School of Medicine Nephrology Department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ege1336
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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