Summary

for people ages 18-100 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Chi-yuan Hsu

Description

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.

Official Title

BOLD: A Trial of Blood Pressure Lowering in Dialysis

Details

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.

Keywords

Blood Pressure End Stage Renal Disease on Dialysis (Diagnosis) Chronic Kidney Diseases Chronic Kidney Disease Stage 5 Hemodialysis End-stage-renal-disease Chronic kidney disease Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Antihypertensive Agents Anti-Hypertensive medications Dry Weight Adjustment Home systolic blood pressure (SBP) <140 mmHg Pre-dialysis SBP <140 mmHg

Eligibility

You can join if…

Open to people ages 18-100

  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

You CAN'T join if...

  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

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of Washington accepting new patients
    Seattle Washington 98104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03459807
Phase
Phase 2
Lead Scientist
Chi-yuan Hsu
Study Type
Interventional
Last Updated
April 9, 2018