Blood Pressure Lowering in Dialysis (BOLD) Trial
Condition: Blood Pressure; End Stage Renal Disease on Dialysis (Diagnosis); Chronic Kidney Diseases; Chronic Kidney Disease Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: Anti-Hypertensive medications; Dry Weight Adjustment
Intervention description: Use of standard Anti-Hypertensive medications; The participant's target post-dialysis dry weight is adjusted
Intervention MeSH terms: Antihypertensive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Blood pressure; Hemodialysis; End-stage-renal-disease; Chronic kidney disease

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.
    

Eligibility 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