Blood Pressure Lowering in Dialysis (BOLD) Trial

Overview

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.

Full Title of Study: “BOLD: A Trial of Blood Pressure Lowering in Dialysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 6, 2018

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.

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility – screen:enrollment ratio
    • Time Frame: 4 months
    • Percentage of eligible participants screened and eventually enrolled in the study
  • 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 Percentage of participants who drop out
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    • Time Frame: Assessed every 2 weeks over 4 months
    • Dialysis unit systolic BP <90 mmHg Dialysis unit systolic BP >200 mmHg Cramping during dialysis Syncope episodes Episodes of fall Episodes of flash pulmonary edema Symptoms of dizziness/lightheadedness/fatigue Duration (in minutes) of recovery from dialysis treatments

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • University of Washington
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chi-yuan Hsu, MD, Principal Investigator, Professor
    • Nisha Bansal, MD, MAS, Principal Investigator, University of Washington

References

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