Blood Pressure Lowering in Dialysis (BOLD) Trial

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease on Dialysis (Diagnosis); Chronic Kidney Diseases; Chronic Kidney Disease Stage 5; Blood Pressure

Treatments: Procedure: Dry Weight Adjustment; Drug: Anti-Hypertensive medications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03459807

R21DK114213 (U.S. NIH Grant/Contract)

16-20963

Details and patient eligibility

About

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 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Home systolic blood pressure (SBP) <140 mmHg

Experimental group

Description:

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.

Treatment:

Procedure: Dry Weight Adjustment

Drug: Anti-Hypertensive medications

Pre-dialysis SBP <140 mmHg

Active Comparator group

Description:

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.

Treatment:

Procedure: Dry Weight Adjustment

Drug: Anti-Hypertensive medications