Status:
COMPLETED
Blood Pressure Lowering in Dialysis (BOLD) Trial
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Blood Pressure
End Stage Renal Disease on Dialysis (Diagnosis)
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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 blo...
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 p...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Undergoing in-center, thrice weekly hemodialysis for treatment of end-stage-renal-disease
- Greater than 3 months since initiation of dialysis
- Age 18 years or above
- Able to obtain a brachial blood pressure at dialysis and at home
Exclusion
- 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
- Incarceration or institutionalized living which may prohibit measurement of home blood pressure
- Participation in another intervention study that may affect blood pressure
- Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
- Hypotension: average pre-dialysis systolic blood pressure \<100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
- Life expectancy \<4 months
- Anticipated living donor kidney transplant within 4 months
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03459807
Start Date
March 23 2018
End Date
December 6 2018
Last Update
July 3 2023
Active Locations (2)
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1
UCSF
San Francisco, California, United States, 94143
2
University of Washington
Seattle, Washington, United States, 98104