Overview

Mechanisms and Treatment of Intradialytic Hypertension

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
1. 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 2. 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Carvedilol
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)