Mechanism and Treatment of Intradialytic Hypertension
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intradialytic Hypertension
Intervention: Carvedilol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Jula K Inrig, MD, MHS, Principal Investigator, Affiliation: UT Southwestern Medical Center
Overall contact:
Jula K Inrig, MD, MHS, Phone: 214-645-8263, Email: jula.inrig@utsouthwestern.edu
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 increased
vascular stiffness (measured by pulse wave velocity) and/or 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 vascular stiffness and/or endothelial
cell dysfunction as surrogate mechanistic markers for improving cardiovascular
outcomes.
Clinical Details
Official title: Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: Endothelial progenitor cells
Secondary outcome: flow mediated vasodilation
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- on hemodialysis > 60 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 neovascularization present, such as neoplasm, active wounds, or
significant retinopathy
- 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)
Locations and Contacts
Jula K Inrig, MD, MHS, Phone: 214-645-8263, Email: jula.inrig@utsouthwestern.edu Additional Information
Starting date: March 2009
Ending date: June 2011
Last updated: January 22, 2009
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