Mechanisms and Treatment of Intradialytic Hypertension

Completed · Phase 4

Conditions studied: Intradialytic Hypertension

In brief

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.

Key facts

Study ID

NCT00827775

Run by

University of Texas Southwestern Medical Center

People needed

55

Starts

2009-06-01

Expected to finish

2010-09-01

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UTSW Oakcliff Davita Dialysis — Dallas, Texas, United States
• UTSW Dallas East Davita Dialysis (Buckner unit) — Dallas, Texas, United States
• UTS Dallas Dialysis (Elmbrook) — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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