CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Carvediloldrug
Likely dose
Carvedilol 6.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00827775
NCT00827775Phase 4Completed
CompareCT.gov

Blood Pressure, Endothelial Cell Dysfunction, and Outcomes in Dialysis Patients

University of Texas Southwestern Medical Center·interventional·Posted Jan 23, 2009·Updated Nov 3, 2020

In Brief

A Phase 4 clinical trial evaluating Carvedilol for Intradialytic Hypertension. Completed, enrolled 55 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntradialytic Hypertension
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

Carvediloldrug

Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid