Clinical trial NCT03459807: Blood Pressure Lowering in Dialysis (BOLD) Trial
Official title: BOLD: A Trial of Blood Pressure Lowering in Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blood Pressure
End Stage Renal Disease on Dialysis (Diagnosis)
Chronic Kidney Diseases
Chronic Kidney Disease Stage 5
Keywords: Blood pressure
Hemodialysis
End-stage-renal-disease
Chronic kidney disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Feasibility - Screen:Enrollment Ratio
timeFrame: Screening
measure: Adherence to Assigned Treatment Arm
timeFrame: 4 months
measure: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Assessed every 2 weeks over 4 months
measure: Mean Duration (in Minutes) of Recovery From Dialysis Treatments
timeFrame: Assessed every 2 weeks; Data averaged over 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Professor
name: Chi-yuan Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Nisha Bansal, MD, MAS
role: PRINCIPAL_INVESTIGATOR
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