Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

University of Texas Southwestern Medical Center3 sites in 1 country55 target enrollmentJune 2009

ConditionsIntradialytic Hypertension

InterventionsCarvedilol

DrugsCarvedilol

Overview

Phase: Phase 4
Intervention: Carvedilol
Conditions: Intradialytic Hypertension
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 55
Locations: 3
Primary Endpoint: Endothelial Progenitor Cells
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

September 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Texas Southwestern Medical Center

Responsible Party

Principal Investigator

Peter Van Buren

Associate Professor of Medicine

University of Texas Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

•on hemodialysis \> 30 days
•aged 18 to 80 years old
•ability to provide informed consent
•Primary nephrologist deems patient is at target dry weight
•Predialysis SBP \>140 or postdialysis SBP\>130

Exclusion Criteria

•Patients with active wounds
•Blood pressure unable to be measured by routine mechanisms in the upper extremity
•Change in blood pressure medications in the previous 2 weeks
•Intolerance of beta or alpha-blockers
•pregnancy
•Resting heart rate \<50
•Life expectancy \< 6 months
•Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)

Arms & Interventions

Intervention

Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions

Intervention: Carvedilol

Outcomes

Primary Outcomes

Endothelial Progenitor Cells

Time Frame: 12 weeks

1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry