Blood Pressure Lowering in Dialysis (BOLD) Trial (BOLD)

June 13, 2023 updated by: University of California, San Francisco

BOLD: A Trial of Blood Pressure Lowering in Dialysis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blood Pressure Lowering in Dialysis (BOLD) is a pilot randomized controlled trial of 50 maintenance hemodialysis patients in San Francisco and Seattle to test whether targeting a home systolic blood pressure <140 mmHg (versus a pre-dialysis systolic blood pressure <140 mmHg) is feasible and safe. The study duration is 4 months and blood pressure targets will be achieved through dry weight adjustment and adjustment of standard anti-hypertensive therapies by the study team. The primary outcomes are focused on feasibility and safety. The home blood pressure treatment arm will also have the opportunity to utilize a blood pressure monitor with Bluetooth capabilities. The rates of utilization of mobile health technology in this population will also be assessed as an outcome. This pilot trial will provide key data to design a larger trial focused on clinical outcomes.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Undergoing in-center, thrice weekly hemodialysis for treatment of end-stage-renal-disease
  3. Greater than 3 months since initiation of dialysis
  4. Age 18 years or above
  5. Able to obtain a brachial blood pressure at dialysis and at home

Exclusion Criteria:

  1. Pregnancy, anticipated pregnancy, or breastfeeding as this will require increase to more than three time a week dialysis and/or preclude use of some classes of blood pressure medications
  2. Incarceration or institutionalized living which may prohibit measurement of home blood pressure
  3. Participation in another intervention study that may affect blood pressure
  4. Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
  5. Hypotension: average pre-dialysis systolic blood pressure <100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
  6. Life expectancy <4 months
  7. Anticipated living donor kidney transplant within 4 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home systolic blood pressure (SBP) <140 mmHg

Participants will be asked to take morning and evening blood pressures every two weeks on a non-dialysis day.

Participants will be asked to transmit these measures to the study team at minimum every 2 weeks either via Bluetooth technology, a manual log, telephone call, text message, e-mail, or verbal communication.

Assigned intervention will be dry weight adjustment and/or adjustment of standard anti-hypertensive medications.
Drug: Anti-Hypertensive medications
Use of standard Anti-Hypertensive medications
Other Names:
  • anti-hypertensive
Procedure: Dry Weight Adjustment
The participant's target post-dialysis dry weight is adjusted
Active Comparator: Pre-dialysis SBP <140 mmHg

Blood pressures taken in the clinical setting at prior to start of dialysis treatment will be recorded.

Assigned intervention will be dry weight adjustment and/or adjustment of standard anti-hypertensive medications.
Drug: Anti-Hypertensive medications
Use of standard Anti-Hypertensive medications
Other Names:
  • anti-hypertensive
Procedure: Dry Weight Adjustment
The participant's target post-dialysis dry weight is adjusted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Screen:Enrollment Ratio
Time Frame: Screening
Percentage of eligible participants screened and eventually enrolled in the study
Screening
Adherence to Assigned Treatment Arm
Time Frame: 4 months
Percentage of participants in the home blood pressure (BP) arm who are able to measure home BP and transmit readings to the research team. Overall, across 16 wks.
4 months
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Assessed every 2 weeks over 4 months
  1. Postdialysis unit systolic BP <90 mmHg
  2. Postdialysis unit systolic BP >200 mmHg
  3. Cramping during dialysis
  4. Syncope episodes
  5. Episodes of fall
  6. Episodes of flash pulmonary edema
  7. Symptoms of dizziness
Assessed every 2 weeks over 4 months
Mean Duration (in Minutes) of Recovery From Dialysis Treatments
Time Frame: Assessed every 2 weeks; Data averaged over 16 weeks
Data were reported at study visits every 2 wks, the mean was calculated from the first to the last follow-up visit. The mean was calculated for each participant, then the overall mean was calculated for each arm.
Assessed every 2 weeks; Data averaged over 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington

Investigators

  • Principal Investigator: Chi-yuan Hsu, MD, Professor
  • Principal Investigator: Nisha Bansal, MD, MAS, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Actual)

December 6, 2018

Study Completion (Actual)

December 6, 2018

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-20963
  • R21DK114213 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Anti-Hypertensive medications

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe