search
Back to results

Blood Pressure Lowering in Dialysis (BOLD) Trial (BOLD)

Primary Purpose

Blood Pressure, End Stage Renal Disease on Dialysis (Diagnosis), Chronic Kidney Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti-Hypertensive medications
Dry Weight Adjustment
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring Blood pressure, Hemodialysis, End-stage-renal-disease, Chronic kidney disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home systolic blood pressure (SBP) <140 mmHg

Pre-dialysis SBP <140 mmHg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility - Screen:Enrollment Ratio
Percentage of eligible participants screened and eventually enrolled in the study
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.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Postdialysis unit systolic BP <90 mmHg Postdialysis unit systolic BP >200 mmHg Cramping during dialysis Syncope episodes Episodes of fall Episodes of flash pulmonary edema Symptoms of dizziness
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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2018
Last Updated
June 13, 2023
Sponsor
University of California, San Francisco
Collaborators
University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03459807
Brief Title
Blood Pressure Lowering in Dialysis (BOLD) Trial
Acronym
BOLD
Official Title
BOLD: A Trial of Blood Pressure Lowering in Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
December 6, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home systolic blood pressure (SBP) <140 mmHg
Arm Type
Experimental
Arm Description
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.
Arm Title
Pre-dialysis SBP <140 mmHg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Anti-Hypertensive medications
Other Intervention Name(s)
anti-hypertensive
Intervention Description
Use of standard Anti-Hypertensive medications
Intervention Type
Procedure
Intervention Name(s)
Dry Weight Adjustment
Intervention Description
The participant's target post-dialysis dry weight is adjusted
Primary Outcome Measure Information:
Title
Feasibility - Screen:Enrollment Ratio
Description
Percentage of eligible participants screened and eventually enrolled in the study
Time Frame
Screening
Title
Adherence to Assigned Treatment Arm
Description
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
Title
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Postdialysis unit systolic BP <90 mmHg Postdialysis unit systolic BP >200 mmHg Cramping during dialysis Syncope episodes Episodes of fall Episodes of flash pulmonary edema Symptoms of dizziness
Time Frame
Assessed every 2 weeks over 4 months
Title
Mean Duration (in Minutes) of Recovery From Dialysis Treatments
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-yuan Hsu, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nisha Bansal, MD, MAS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12493255
Citation
Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. Erratum In: Lancet. 2003 Mar 22;361(9362):1060.
Results Reference
background
PubMed Identifier
7586343
Citation
Flack JM, Neaton J, Grimm R Jr, Shih J, Cutler J, Ensrud K, MacMahon S. Blood pressure and mortality among men with prior myocardial infarction. Multiple Risk Factor Intervention Trial Research Group. Circulation. 1995 Nov 1;92(9):2437-45. doi: 10.1161/01.cir.92.9.2437.
Results Reference
background
PubMed Identifier
1969518
Citation
MacMahon S, Peto R, Cutler J, Collins R, Sorlie P, Neaton J, Abbott R, Godwin J, Dyer A, Stamler J. Blood pressure, stroke, and coronary heart disease. Part 1, Prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet. 1990 Mar 31;335(8692):765-74. doi: 10.1016/0140-6736(90)90878-9.
Results Reference
background
PubMed Identifier
22936794
Citation
Vamos EP, Harris M, Millett C, Pape UJ, Khunti K, Curcin V, Molokhia M, Majeed A. Association of systolic and diastolic blood pressure and all cause mortality in people with newly diagnosed type 2 diabetes: retrospective cohort study. BMJ. 2012 Aug 30;345:e5567. doi: 10.1136/bmj.e5567.
Results Reference
background
PubMed Identifier
24352797
Citation
James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum In: JAMA. 2014 May 7;311(17):1809.
Results Reference
background
PubMed Identifier
26551272
Citation
SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.
Results Reference
background
PubMed Identifier
14604997
Citation
Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. doi: 10.1161/01.HYP.0000102971.85504.7c. No abstract available.
Results Reference
background
PubMed Identifier
11443763
Citation
Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.
Results Reference
background
PubMed Identifier
11675417
Citation
Locatelli F, Marcelli D, Conte F, D'Amico M, Vecchio LD, Limido A, Malberti F, Spotti D. Survival and development of cardiovascular disease by modality of treatment in patients with end-stage renal disease. J Am Soc Nephrol. 2001 Nov;12(11):2411-2417. doi: 10.1681/ASN.V12112411.
Results Reference
background
PubMed Identifier
27226131
Citation
Ok E, Asci G, Chazot C, Ozkahya M, Mees EJ. Controversies and problems of volume control and hypertension in haemodialysis. Lancet. 2016 Jul 16;388(10041):285-93. doi: 10.1016/S0140-6736(16)30389-0. Epub 2016 May 22.
Results Reference
background
PubMed Identifier
12631061
Citation
Kalantar-Zadeh K, Block G, Humphreys MH, Kopple JD. Reverse epidemiology of cardiovascular risk factors in maintenance dialysis patients. Kidney Int. 2003 Mar;63(3):793-808. doi: 10.1046/j.1523-1755.2003.00803.x.
Results Reference
background
PubMed Identifier
8743547
Citation
Duranti E, Imperiali P, Sasdelli M. Is hypertension a mortality risk factor in dialysis? Kidney Int Suppl. 1996 Jun;55:S173-4.
Results Reference
background
PubMed Identifier
9690224
Citation
Zager PG, Nikolic J, Brown RH, Campbell MA, Hunt WC, Peterson D, Van Stone J, Levey A, Meyer KB, Klag MJ, Johnson HK, Clark E, Sadler JH, Teredesai P. "U" curve association of blood pressure and mortality in hemodialysis patients. Medical Directors of Dialysis Clinic, Inc. Kidney Int. 1998 Aug;54(2):561-9. doi: 10.1046/j.1523-1755.1998.00005.x. Erratum In: Kidney Int 1998 Oct;54(4):1417.
Results Reference
background
PubMed Identifier
10886582
Citation
Cheung AK, Sarnak MJ, Yan G, Dwyer JT, Heyka RJ, Rocco MV, Teehan BP, Levey AS. Atherosclerotic cardiovascular disease risks in chronic hemodialysis patients. Kidney Int. 2000 Jul;58(1):353-62. doi: 10.1046/j.1523-1755.2000.00173.x.
Results Reference
background
PubMed Identifier
20083728
Citation
Agarwal R. Blood pressure and mortality among hemodialysis patients. Hypertension. 2010 Mar;55(3):762-8. doi: 10.1161/HYPERTENSIONAHA.109.144899. Epub 2010 Jan 18.
Results Reference
background
PubMed Identifier
24026256
Citation
Kovesdy CP, Bleyer AJ, Molnar MZ, Ma JZ, Sim JJ, Cushman WC, Quarles LD, Kalantar-Zadeh K. Blood pressure and mortality in U.S. veterans with chronic kidney disease: a cohort study. Ann Intern Med. 2013 Aug 20;159(4):233-42. doi: 10.7326/0003-4819-159-4-201308200-00004.
Results Reference
background
PubMed Identifier
22718187
Citation
Robinson BM, Tong L, Zhang J, Wolfe RA, Goodkin DA, Greenwood RN, Kerr PG, Morgenstern H, Li Y, Pisoni RL, Saran R, Tentori F, Akizawa T, Fukuhara S, Port FK. Blood pressure levels and mortality risk among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2012 Sep;82(5):570-80. doi: 10.1038/ki.2012.136. Epub 2012 Jun 20.
Results Reference
background
PubMed Identifier
10070915
Citation
Port FK, Hulbert-Shearon TE, Wolfe RA, Bloembergen WE, Golper TA, Agodoa LY, Young EW. Predialysis blood pressure and mortality risk in a national sample of maintenance hemodialysis patients. Am J Kidney Dis. 1999 Mar;33(3):507-17. doi: 10.1016/s0272-6386(99)70188-5.
Results Reference
background
PubMed Identifier
32800842
Citation
Bansal N, Glidden DV, Mehrotra R, Townsend RR, Cohen J, Linke L, Palad F, Larson H, Hsu CY. Treating Home Versus Predialysis Blood Pressure Among In-Center Hemodialysis Patients: A Pilot Randomized Trial. Am J Kidney Dis. 2021 Jan;77(1):12-22. doi: 10.1053/j.ajkd.2020.06.014. Epub 2020 Aug 13.
Results Reference
result

Learn more about this trial

Blood Pressure Lowering in Dialysis (BOLD) Trial

We'll reach out to this number within 24 hrs