CompletedInterventionalPhase 4Updated Nov 18, 2014
Mechanisms and Treatment of Intradialytic Hypertension | NCT00827775 | Trialant
CompletedInterventionalPhase 4Updated Nov 3, 2020
Mechanisms and Treatment of Intradialytic Hypertension
Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
ClinicalTrials.gov ID
NCT00827775
Lead Sponsor
University of Texas Southwestern Medical CenterOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
55Actual
Last Update Posted
Nov 3, 2020Actual
Start Date
Jun 2009
Primary Completion Date
Sep 2010Actual
Completion Date
Sep 2010Actual
Official Title
Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
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.
Intradialytic Hypertension
Carvedilol
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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)
Primary Purpose
Treatment
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
UTSW Oakcliff Davita Dialysis
Dallas, Texas 75224, United States
UTSW Dallas East Davita Dialysis (Buckner unit)
Dallas, Texas 75228, United States
UTS Dallas Dialysis (Elmbrook)
Dallas, Texas 75247, United States
Lead Sponsor
University of Texas Southwestern Medical CenterOTHER
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)NIH