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

NCT00307463 | Completed Phase 4 DMC

• 1 other identifier: Ege1336
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

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.

Conditions

End-stage Renal Disease

Keywords

end-stage renal disease; hemodialysis; volume control; ultrafiltration; inflammation; cardiovascular disease; left ventricular hypertrophy; dietary salt restriction

Outcome Measures

Primary Outcomes (3)

• regression of left ventricular hypertrophy

  one year

• regression of left ventricular mass

  one year

• change in left ventricular end-diastolic volume

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (2)

strict volume control policy

ACTIVE COMPARATOR

strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.

Procedure: strict volume control policy

antihypertensive drugs administration

OTHER

antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

Procedure: antihypertensive drugs administration

Interventions

strict volume control policy PROCEDURE

strict volume control by UF and dietary salt restriction

strict volume control policy

antihypertensive drugs administration PROCEDURE

continue antihypertensive medications

antihypertensive drugs administration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Adana Numune Research and Education Hospital

Adana, Adana, 01100, Turkey (Türkiye)

Location

Ege University School of Medicine Division of Nephrology

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation; Cardiovascular Diseases; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical

Study Officials

• Ercan Ok, M.D

  Ege University School of Medicine Nephrology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

TU (2)