| Trial ID: | L0736 |
| Source ID: | NCT03459807
|
| Associated Drug: |
Anti-Hypertensive Medications
|
| Title: |
Blood Pressure Lowering in Dialysis (BOLD) Trial
|
| Acronym: |
BOLD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03459807/results
|
| Conditions: |
Blood Pressure|End Stage Renal Disease on Dialysis (Diagnosis)|Chronic Kidney Diseases|Chronic Kidney Disease Stage 5
|
| Interventions: |
DRUG: Anti-Hypertensive medications|PROCEDURE: Dry Weight Adjustment
|
| Outcome Measures: |
Primary: Feasibility - Screen:Enrollment Ratio, Percentage of eligible participants screened and eventually enrolled in the study, Screening|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., 4 months|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, Assessed every 2 weeks over 4 months|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., Assessed every 2 weeks; Data averaged over 16 weeks |
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Francisco | Collaborators: University of Washington|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-03-23
|
| Completion Date: |
2018-12-06
|
| Results First Posted: |
2023-07-03
|
| Last Update Posted: |
2023-07-03
|
| Locations: |
UCSF, San Francisco, California, 94143, United States|University of Washington, Seattle, Washington, 98104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03459807
|
