Blood Pressure Lowering in Dialysis (BOLD) Trial

• Status: Completed
• Trial end date: 2019-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: University of Washington
• Treatments: Antihypertensive Agents

Criteria

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