Clinical trial NCT00827775: Mechanisms and Treatment of Intradialytic Hypertension
Official title: Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intradialytic Hypertension
Keywords: Hypertension
Hemodialysis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-01-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 outcomes:
measure: Endothelial Progenitor Cells
timeFrame: 12 weeks
Secondary outcomes:
measure: Flow Mediated Vasodilation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTSW Oakcliff Davita Dialysis
state: Texas
city: Dallas
country: United States
facility: UTSW Dallas East Davita Dialysis (Buckner unit)
state: Texas
city: Dallas
country: United States
facility: UTS Dallas Dialysis (Elmbrook)
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jula K Inrig, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto R. Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction. Clin J Am Soc Nephrol. 2012 Aug;7(8):1300-9. doi: 10.2215/CJN.10010911. Epub 2012 Jun 14.
citation: Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto RD. Intradialytic hypertension and its association with endothelial cell dysfunction. Clin J Am Soc Nephrol. 2011 Aug;6(8):2016-24. doi: 10.2215/CJN.11351210. Epub 2011 Jul 14.
citation: Van Buren PN, Kim C, Toto R, Inrig JK. Intradialytic hypertension and the association with interdialytic ambulatory blood pressure. Clin J Am Soc Nephrol. 2011 Jul;6(7):1684-91. doi: 10.2215/CJN.11041210.