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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307463
• Other study ID #: Ege1336
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: September 6, 2013
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: September 2013
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• strict volume control policy
strict volume control by UF and dietary salt restriction
• antihypertensive drugs administration
continue antihypertensive medications

Locations

Country	Name	City	State
Turkey	Adana Numune Research and Education Hospital	Adana
Turkey	Ege University School of Medicine Division of Nephrology	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regression of left ventricular hypertrophy		one year	No
Primary	regression of left ventricular mass		one year	No
Primary	change in left ventricular end-diastolic volume		one year	No
Secondary	change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels		one year	No