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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ercan OK, Ege University
ClinicalTrials.gov Identifier:
NCT00307463
First received: March 27, 2006
Last updated: September 6, 2013
Last verified: September 2013
  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
Procedure: strict volume control policy
Procedure: antihypertensive drugs administration
Phase 4

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:


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: strict volume control policy
strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
Procedure: strict volume control policy
strict volume control by UF and dietary salt restriction
Other Name: strict volume control policy
antihypertensive drugs administration
antihypertensive drugs administration: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.
Procedure: antihypertensive drugs administration
continue antihypertensive medications
Other Name: antihypertensive drugs administration

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Ercan OK, professor, Ege University
ClinicalTrials.gov Identifier: NCT00307463     History of Changes
Other Study ID Numbers: Ege1336
Study First Received: March 27, 2006
Last Updated: September 6, 2013
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 September 18, 2014