Blood Pressure Lowering in Dialysis (BOLD) Trial

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.

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