Trial Outcomes & Findings for Blood Pressure Lowering in Dialysis (BOLD) Trial (NCT NCT03459807)

NCT ID: NCT03459807

Last Updated: 2023-07-03

Results Overview

Percentage of eligible participants screened and eventually enrolled in the study

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Screening
• Results posted on: 2023-07-03

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	25	25
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal due to transplant	0	1

Baseline Characteristics

Blood Pressure Lowering in Dialysis (BOLD) Trial

Baseline characteristics by cohort

Measure	Home Systolic Blood Pressure (SBP) <140 mmHg n=25 Participants 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	Pre-dialysis SBP <140 mmHg n=25 Participants 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	Total n=50 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 13.1 • n=5 Participants	56.9 years STANDARD_DEVIATION 14.4 • n=7 Participants	56.6 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Screening

Percentage of eligible participants screened and eventually enrolled in the study

Outcome measures

Measure	Participants Screened n=70 Participants Prescreened (through EMR and/or contact with nephrologists) and approached for participation in the study.	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
Feasibility - Screen:Enrollment Ratio	50 Participants	—

PRIMARY outcome

Timeframe: 4 months

Population: Only the home systolic blood pressure group tested blood pressure at home

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.

Outcome measures

Measure	Participants Screened n=25 Participants Prescreened (through EMR and/or contact with nephrologists) and approached for participation in the study.	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
Adherence to Assigned Treatment Arm 0 BP Readings	3 percentage of participants	—
Adherence to Assigned Treatment Arm 1 BP Reading	4 percentage of participants	—
Adherence to Assigned Treatment Arm 2 BP Readings	93 percentage of participants	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Participants Screened n=25 Participants Prescreened (through EMR and/or contact with nephrologists) and approached for participation in the study.	Pre-dialysis SBP <140 mmHg n=25 Participants 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
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Symptoms of dizziness	10 Participants	14 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Episodes of flash pulmonary edema	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Postdialysis unit systolic BP <90 mmHg	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Postdialysis unit systolic BP >200 mmHg	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Cramping during dialysis	13 Participants	18 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Syncope episodes	1 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] Episodes of fall	3 Participants	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Participants Screened n=25 Participants Prescreened (through EMR and/or contact with nephrologists) and approached for participation in the study.	Pre-dialysis SBP <140 mmHg n=25 Participants 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
Mean Duration (in Minutes) of Recovery From Dialysis Treatments	327 Minutes Standard Deviation 42	268 Minutes Standard Deviation 37

Adverse Events

Home Systolic Blood Pressure (SBP) <140 mmHg

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Dialysis SBP <140 mmHg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Home Systolic Blood Pressure (SBP) <140 mmHg n=25 participants at risk 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	Dialysis SBP <140 mmHg n=25 participants at risk 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
Cardiac disorders Syncope	8.0% 2/25 • 16 weeks	4.0% 1/25 • 16 weeks

Other adverse events

Measure	Home Systolic Blood Pressure (SBP) <140 mmHg n=25 participants at risk 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	Dialysis SBP <140 mmHg n=25 participants at risk 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
General disorders Fall	12.0% 3/25 • 16 weeks	24.0% 6/25 • 16 weeks
Musculoskeletal and connective tissue disorders Cramping	52.0% 13/25 • 16 weeks	72.0% 18/25 • 16 weeks
General disorders Symptoms of dizziness	40.0% 10/25 • 16 weeks	56.0% 14/25 • 16 weeks
General disorders Symptoms of lightheadedness	56.0% 14/25 • 16 weeks	48.0% 12/25 • 16 weeks
Cardiac disorders Predialysis SBP < 90 mm Hg	4.0% 1/25 • 16 weeks	8.0% 2/25 • 16 weeks
Cardiac disorders Postdialysis SBP < 90 mm Hg	8.0% 2/25 • 16 weeks	0.00% 0/25 • 16 weeks
Cardiac disorders Predialysis SBP > 200 mm Hg	16.0% 4/25 • 16 weeks	16.0% 4/25 • 16 weeks
Cardiac disorders Postdialysis SBP > 200 mm Hg	12.0% 3/25 • 16 weeks	8.0% 2/25 • 16 weeks
General disorders Symptoms of fatigue	60.0% 15/25 • 16 weeks	64.0% 16/25 • 16 weeks
Cardiac disorders Intradialytic hypotension	84.0% 21/25 • 16 weeks	72.0% 18/25 • 16 weeks

Additional Information

Dr. Chi-yuan Hsu

University of California, San Francisco

Phone: 415-476-2172

Email: chi-yuan.hsu@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place