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NCT Number: NCT03459807

Blood Pressure Lowering in Dialysis (BOLD) Trial

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.

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Key information

Conditions

Blood Pressure Chronic Disease Chronic Kidney Disease Stage 5 Chronic Kidney Diseases Disease Disease Attributes End Stage Renal Disease on Dialysis (Diagnosis) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSF, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Incarceration or institutionalized living which may prohibit measurement of home blood pressure
  • Participation in another intervention study that may affect blood pressure
  • Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
  • Hypotension: average pre-dialysis systolic blood pressure <100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
  • Life expectancy <4 months
  • Anticipated living donor kidney transplant within 4 months

Treatment and study plan

Anti-Hypertensive medications

Drug

Use of standard Anti-Hypertensive medications

Other names: anti-hypertensive

Dry Weight Adjustment

Procedure

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

Primary outcomes

  1. Feasibility - Screen:Enrollment Ratio

    Time frame: Screening

    Percentage of eligible participants screened and eventually enrolled in the study

  2. 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.

  3. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Assessed every 2 weeks over 4 months

    • Postdialysis unit systolic BP <90 mmHg
    • Postdialysis unit systolic BP >200 mmHg
    • Cramping during dialysis
    • Syncope episodes
    • Episodes of fall
    • Episodes of flash pulmonary edema
    • Symptoms of dizziness

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

BOLD: A Trial of Blood Pressure Lowering in Dialysis

Acronym: BOLD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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