Blood Pressure, Chronic Kidney Diseases, Chronic Kidney Disease Stage 5, End Stage Renal Disease on Dialysis (Diagnosis)
Conditions
Keywords
Blood pressure, Hemodialysis, End-stage-renal-disease, Chronic kidney disease
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.
Interventions
Use of standard Anti-Hypertensive medications
PROCEDUREDry Weight Adjustment
The participant's target post-dialysis dry weight is adjusted
Sponsors
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Screen:Enrollment Ratio | Screening | Percentage of eligible participants screened and eventually enrolled in the study |
| Adherence to Assigned Treatment Arm | 4 months | Percentage of participants in the home blood pressure (BP) arm who are able to measure home BP and transmit readings to the research team. Overall, across 16 wks. |
| Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Assessed every 2 weeks over 4 months | 1. Postdialysis unit systolic BP \<90 mmHg 2. Postdialysis unit systolic BP \>200 mmHg 3. Cramping during dialysis 4. Syncope episodes 5. Episodes of fall 6. Episodes of flash pulmonary edema 7. Symptoms of dizziness |
| Mean Duration (in Minutes) of Recovery From Dialysis Treatments | Assessed every 2 weeks; Data averaged over 16 weeks | Data were reported at study visits every 2 wks, the mean was calculated from the first to the last follow-up visit. The mean was calculated for each participant, then the overall mean was calculated for each arm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Systolic Blood Pressure (SBP) <140 mmHg 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.
Anti-Hypertensive medications: Use of standard Anti-Hypertensive medications
Dry Weight Adjustment: The participant's target post-dialysis dry weight is adjusted | 25 |
| Pre-dialysis SBP <140 mmHg 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.
Anti-Hypertensive medications: Use of standard Anti-Hypertensive medications
Dry Weight Adjustment: The participant's target post-dialysis dry weight is adjusted | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal due to transplant | 0 | 1 |
Baseline characteristics
| Characteristic | Home Systolic Blood Pressure (SBP) <140 mmHg | Total | Pre-dialysis SBP <140 mmHg |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 13.1 | 56.6 years STANDARD_DEVIATION 13.6 | 56.9 years STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 20 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 14 Participants | 8 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 12 Participants | 20 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 30 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 25 / 25 | 25 / 25 |
| serious Total, serious adverse events | 2 / 25 | 1 / 25 |
Outcome results
Primary
Adherence to Assigned Treatment Arm
Percentage of participants in the home blood pressure (BP) arm who are able to measure home BP and transmit readings to the research team. Overall, across 16 wks.
Time frame: 4 months
Population: Only the home systolic blood pressure group tested blood pressure at home
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Screened | Adherence to Assigned Treatment Arm | 0 BP Readings | 3 percentage of participants |
| Participants Screened | Adherence to Assigned Treatment Arm | 1 BP Reading | 4 percentage of participants |
| Participants Screened | Adherence to Assigned Treatment Arm | 2 BP Readings | 93 percentage of participants |
Primary
Feasibility - Screen:Enrollment Ratio
Percentage of eligible participants screened and eventually enrolled in the study
Time frame: Screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Screened | Feasibility - Screen:Enrollment Ratio | 50 Participants |
Primary
Mean Duration (in Minutes) of Recovery From Dialysis Treatments
Data were reported at study visits every 2 wks, the mean was calculated from the first to the last follow-up visit. The mean was calculated for each participant, then the overall mean was calculated for each arm.
Time frame: Assessed every 2 weeks; Data averaged over 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Screened | Mean Duration (in Minutes) of Recovery From Dialysis Treatments | 327 Minutes | Standard Deviation 42 |
| Pre-dialysis SBP <140 mmHg | Mean Duration (in Minutes) of Recovery From Dialysis Treatments | 268 Minutes | Standard Deviation 37 |
Primary
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
1. Postdialysis unit systolic BP \<90 mmHg 2. Postdialysis unit systolic BP \>200 mmHg 3. Cramping during dialysis 4. Syncope episodes 5. Episodes of fall 6. Episodes of flash pulmonary edema 7. Symptoms of dizziness
Time frame: Assessed every 2 weeks over 4 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Cramping during dialysis | 13 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Episodes of fall | 3 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Postdialysis unit systolic BP >200 mmHg | 3 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Episodes of flash pulmonary edema | 0 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Syncope episodes | 1 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Symptoms of dizziness | 10 Participants |
| Participants Screened | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Postdialysis unit systolic BP <90 mmHg | 2 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Symptoms of dizziness | 14 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Postdialysis unit systolic BP <90 mmHg | 0 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Postdialysis unit systolic BP >200 mmHg | 2 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Cramping during dialysis | 18 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Syncope episodes | 1 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Episodes of fall | 6 Participants |
| Pre-dialysis SBP <140 mmHg | Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] | Episodes of flash pulmonary edema | 0 Participants |