CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Anti-Hypertensive medications +1 moredrug
Likely dose
Not stated in 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/NCT03459807
NCT03459807Phase 2Completed

BOLD: A Trial of Blood Pressure Lowering in Dialysis

University of California, San Francisco·interventional·Posted Mar 9, 2018·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating Anti-Hypertensive medications and Dry Weight Adjustment for Blood Pressure and 3 related conditions. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

Blood pressure may be one of the most important modifiable risk factors for cardiovascular disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis. Although a systolic blood pressure \<140 mmHg treatment target has been recommended, there remains uncertainty on which blood pressure should be targeted, more specifically that measured in the dialysis unit or at home. Observational studies have reported a paradoxical U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with poor outcomes). Conversely, the same studies have reported a linear association between higher home systolic blood pressure and worse clinical outcomes, where blood pressure below 140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this important question.

Study Details

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 9, 2018
Enrollment StartMar 23, 2018
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago

Interventions

Anti-Hypertensive medicationsdrug

Use of standard Anti-Hypertensive medications

Dry Weight Adjustmentprocedure

The participant's target post-dialysis dry weight is adjusted