Phase 4 N=55 Treatment

Mechanisms and Treatment of Intradialytic Hypertension

Intradialytic Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00827775 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Nov 2020

Primary outcome: Primary: Endothelial Progenitor Cells — 0.052; 0.034; 0.027; 0.059 % of mononuclear cells

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Carvedilol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Endothelial Progenitor Cells	0.052; 0.034; 0.027; 0.059; 0.033; 0.029	—
SECONDARY Flow Mediated Vasodilation	1.67; 1.03; 1.4	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00827775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.