Blood PressurePhase 2BOLDNCT03459807
Blood Pressure Lowering in Dialysis (BOLD) Trial
A Phase 2 study testing Anti-Hypertensive medications and Dry Weight Adjustment in people with Blood Pressure and End Stage Renal Disease on Dialysis (Diagnosis), run by University of California, San Francisco at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Blood Pressure, End Stage Renal Disease on Dialysis (Diagnosis), Chronic Kidney Diseases
- What is being tested?
- Anti-Hypertensive medications and Dry Weight Adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2018to 6 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSF
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98104
About this study
Official title: BOLD: A Trial of Blood Pressure Lowering in Dialysis
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.
Read the 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.
- Conditions
- Blood Pressure, End Stage Renal Disease on Dialysis (Diagnosis), Chronic Kidney Diseases, Chronic Kidney Disease Stage 5
- Being tested
- Anti-Hypertensive medications, Dry Weight Adjustment
- Keywords
- Blood pressure, Hemodialysis, End-stage-renal-disease, Chronic kidney disease
- Medical subject headings
- Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Hypertensive medicationsDrug
Also called anti-hypertensive
Use of standard Anti-Hypertensive medications
Dry Weight AdjustmentProcedure or surgery
The participant's target post-dialysis dry weight is adjusted
| Study group | Role | What they receive |
|---|---|---|
| Home systolic blood pressure (SBP) <140 mmHg | Experimental | 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. Receives: Drug: Anti-Hypertensive medications; Procedure: Dry Weight Adjustment |
| Pre-dialysis SBP <140 mmHg | Active comparator | 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. Receives: Drug: Anti-Hypertensive medications; Procedure: Dry Weight Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Screen:Enrollment Ratio
Percentage of eligible participants screened and eventually enrolled in the study
Measured: 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.
Measured: 4 months
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
Measured: 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.
Measured: Assessed every 2 weeks; Data averaged over 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start23 Mar 2018
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Chi-yuan Hsu, MD, Principal investigator, ProfessorNisha Bansal, MD, MAS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459807
- Sponsor's protocol ID
- 16-20963
- Other IDs
- R21DK114213
- Acronym
- BOLD
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2018
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12493255Flack 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.
PubMed 7586343MacMahon 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.
PubMed 1969518Vamos 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.
PubMed 22936794James 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.
PubMed 24352797SPRINT 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.
PubMed 26551272Sarnak 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.
PubMed 14604997Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.
PubMed 11443763Locatelli 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.
PubMed 11675417Ok 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.
PubMed 27226131Kalantar-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.
PubMed 12631061Duranti E, Imperiali P, Sasdelli M. Is hypertension a mortality risk factor in dialysis? Kidney Int Suppl. 1996 Jun;55:S173-4.
PubMed 8743547Zager 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.
PubMed 9690224Cheung 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.
PubMed 10886582Agarwal 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.
PubMed 20083728
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOLD: A Trial of Blood Pressure Lowering in Dialysis
- ClinicalTrials.gov ID
- NCT03459807
- Acronym / sponsor ID
- BOLD / 16-20963
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home systolic blood pressure (SBP) <140 mmHg | Experimental | Drug: Anti-Hypertensive medications, Procedure: Dry Weight AdjustmentParticipants 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. |
| Pre-dialysis SBP <140 mmHg | Active comparator | Drug: Anti-Hypertensive medications, Procedure: Dry Weight AdjustmentBlood 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Hypertensive medicationsAlso: anti-hypertensiveUse of standard Anti-Hypertensive medications | Drug | Home systolic blood pressure (SBP) <140 mmHg, Pre-dialysis SBP <140 mmHg |
| Dry Weight AdjustmentThe participant's target post-dialysis dry weight is adjusted | Procedure or surgery | Home systolic blood pressure (SBP) <140 mmHg, Pre-dialysis SBP <140 mmHg |
Primary outcome
Feasibility - Screen:Enrollment Ratio
Time frame: Screening
Percentage of eligible participants screened and eventually enrolled in the study
Adherence to Assigned Treatment Arm
Time frame: 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]
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12493255Lewington 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.
- Background: PubMed 7586343Flack 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.
- Background: PubMed 1969518MacMahon 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.
- Background: PubMed 22936794Vamos 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.
- Background: PubMed 24352797James 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.
- Background: PubMed 26551272SPRINT 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.
- Background: PubMed 14604997Sarnak 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.
- Background: PubMed 11443763Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.
- Background: PubMed 11675417Locatelli 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.
- Background: PubMed 27226131Ok 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.
- Background: PubMed 12631061Kalantar-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.
- Background: PubMed 8743547Duranti E, Imperiali P, Sasdelli M. Is hypertension a mortality risk factor in dialysis? Kidney Int Suppl. 1996 Jun;55:S173-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-yuan Hsu, MD principal investigator
Professor
Nisha Bansal, MD, MAS principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-Hypertensive medications and Dry Weight Adjustment in people with Blood Pressure and End Stage Renal Disease on Dialysis (Diagnosis), run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Screen:Enrollment Ratio (time frame: Screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459807, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.