Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation - Full Text View

Sponsor:	Ege University
Information provided by:	Ege University
ClinicalTrials.gov Identifier:	NCT00307463

Purpose

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
End-Stage Renal Disease Hemodialysis	Procedure: strict volume control Procedure: antihypertensive medications	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Dialysis Dietary Sodium Kidney Failure

U.S. FDA Resources

Further study details as provided by Ege University:

Primary Outcome Measures:

regression of left ventricular hypertrophy [ Time Frame: one year ] [ Designated as safety issue: No ]
regression of left ventricular mass [ Time Frame: one year ] [ Designated as safety issue: No ]
change in left ventricular end-diastolic volume [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels [ Time Frame: one year ] [ Designated as safety issue: No ]

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
Active Comparator: 1 strict volume control policy	Procedure: strict volume control strict volume control by UF and dietary salt restriction
2 antihypertensive drugs administration	Procedure: antihypertensive medications continue antihypertensive medications

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307463

Locations

Turkey
Ege University School of Medicine Division of Nephrology
Bornova, Izmir, Turkey, 35100
Adana Numune Research and Education Hospital
Adana, Turkey, 01100

Sponsors and Collaborators

Ege University

Investigators

Study Chair:

Ercan Ok, M.D

Ege University School of Medicine Nephrology Department

More Information

No publications provided

Responsible Party:	Ege University
ClinicalTrials.gov Identifier:	NCT00307463 History of Changes
Other Study ID Numbers:	Ege1336
Study First Received:	March 27, 2006
Last Updated:	August 3, 2009
Health Authority:	Turkey: Ministry of Health

Keywords provided by Ege University:

end-stage renal disease
hemodialysis
volume control
ultrafiltration

inflammation
cardiovascular disease
left ventricular hypertrophy
dietary salt restriction

Additional relevant MeSH terms:

Inflammation
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic

Renal Insufficiency
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012