MedTrace Logo

Blood Pressure Lowering in Dialysis (BOLD) Trial

NCT03459807 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Blood Pressure
  • End Stage Renal Disease on Dialysis (Diagnosis)
  • Chronic Kidney Diseases
  • Chronic Kidney Disease Stage 5

Interventions

DRUG

Anti-Hypertensive medications

Use of standard Anti-Hypertensive medications

PROCEDURE

Dry Weight Adjustment

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

Sponsors & Collaborators

Principal Investigators

  • Chi-yuan Hsu, MD · Professor

  • Nisha Bansal, MD, MAS · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2018-12-06
Completion
2018-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459807 on ClinicalTrials.gov