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

Tracking Information

First Received Date ^ICMJE

March 27, 2006

Last Updated Date

August 3, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

regression of left ventricular hypertrophy
regression of left ventricular mass
change in left ventricular end-diastolic volume

Change History

Complete list of historical versions of study NCT00307463 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels

Descriptive Information

Brief Title ^ICMJE

Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation

Official Title ^ICMJE

Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study

Brief Summary

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

End-Stage Renal Disease
Hemodialysis

Intervention ^ICMJE

Procedure: strict volume control
Procedure: antihypertensive medications

Study Arms / Comparison Groups

Active Comparator: strict volume control policy
Other: antihypertensive drugs administration

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

258

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT ID ^ICMJE

NCT00307463

Responsible Party

Ege University, Ege University

Study ID Numbers ^ICMJE

Ege1336

Study Sponsor ^ICMJE

Ege University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Ercan Ok, M.D

Ege University School of Medicine Nephrology Department

Information Provided By

Ege University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP