Mechanisms and Treatment of Intradialytic Hypertension

Phase 4

Completed

• Conditions: Intradialytic Hypertension
• Interventions: Drug: Carvedilol

• Registration Number: NCT00827775
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Study Start: 2009-06
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2020-10
• Results First Submitted: 2020-10-12
• Results First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Results First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Carvedilol	Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions

Primary Outcome Measures

Name	Time	Method
Endothelial Progenitor Cells	12 weeks	1. ALDH bright cells reported as percentage of mononuclear cells. These were assayed using flow cytometry; 2. CD34/CD133 endothelial progenitor cells reported as percentage of mononuclear cells. These were assayed using flow cytometry

Secondary Outcome Measures

Name	Time	Method
Flow Mediated Vasodilation	12 weeks	Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later

Trial Locations

Locations (3)

UTS Dallas Dialysis (Elmbrook); 🇺🇸 Dallas, Texas, United States

UTSW Oakcliff Davita Dialysis; 🇺🇸 Dallas, Texas, United States

UTSW Dallas East Davita Dialysis (Buckner unit); 🇺🇸 Dallas, Texas, United States