HypertensionBIDNCT01421771
Blood Pressure in Dialysis Patients
A study testing Antihypertensive Agents, Dry weight Challenge and Extend dialysis treatment time and re-challenge estimated dry weight in people with Hypertension and Renal Failure Chronic Requiring Hemodialysis, run by University of New Mexico at 21 sites in United States.
Trial summary
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renal Failure Chronic Requiring Hemodialysis, Blood Pressure
- What is being tested?
- Antihypertensive Agents, Dry weight Challenge and Extend dialysis treatment time and re-challenge estimated dry weight
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2011to Jun 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- On thrice weekly maintenance hemodialysis for greater than 90 days
- For entry into baseline period: 2-week average RDUSBPM > 155 mm Hg on AHT medications or < 155 mm Hg on ≥ 1 AHT medications For randomization: 2-week average SDUSBPM ≥ 155 mm Hg
Who cannot join
- Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
- Inability to measure blood pressures in an upper arm;
- History of inter or post-dialytic hypotension (defined as systolic blood pressure <90 mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring hospitalization (including emergency room visit) and/or the use of midodrine in the past 6 months;
- Required one or more urgent, unscheduled dialysis treatment for congestive heart failure in the past 3 months (other than in an incident patient at the time of starting dialysis);
- Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
- Severe aortic valve stenosis (valve area <1cm 2) carotid artery stenosis (>70% stenosis);
Show all 24Show fewer
- Known abdominal aortic aneurysm >5 cm in diameter or thoracic aortic aneurysm of any diameter;
- Body mass index >40 kg/m2 or arm circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff;
- Life expectancy <1 year;
- A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within the next year;
- Significant cognitive impairment;
- spKt/V ≤1.2 in the past 2 months;
- Active liver disease;
- Active alcohol or substance abuse including narcotics within the past year;
- Contraindication to cardiac MRI;
- Current or planned pregnancy within the next year;
- Unwillingness to consent to pregnancy test and/or use of birth control if of childbearing potential;
- Suspicion that the participant will not be willing or able to adhere to prescribed medications and study protocol;
- Incarcerated;
- Significant concern about the study expressed by spouse, significant other, family member primary nephrologist or primary care physician;
- Participation in another intervention study;
- Unable to speak or understand English or Spanish;
- Plan to relocate within one year;
- participation in another intervention study .
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Dialysis Clinic Inc - Albuquerque
Albuquerque, New Mexico, 87102
Dialysis Clinic Inc - Albuquerque South
Albuquerque, New Mexico, 87105
Dialysis Clinic Inc - Albuquerque East
Albuquerque, New Mexico, 87110
Dialysis Clinic Inc - Boston
Boston, Massachusetts, 02111
DaVita Boston
Boston, Massachusetts, 02118
Dialysis Clinic Inc - Magnolia Court
Charleston, South Carolina, 29403
Dialysis Clinic Inc - West Ashley
Charleston, South Carolina, 29407
Dialysis Clinic Inc - James Island
Charleston, South Carolina, 29412
Centers for Dialysis Care East
Cleveland, Ohio, 44106
Centers for Dialysis Care - Shaker Heights
Cleveland, Ohio, 44122
Dialysis Clinic Inc - Walden Pond Clinic
Concord, Massachusetts, 01742
Dialysis Clinic Inc - Grants
Grants, New Mexico, 87020
Dialysis Clinic Inc - Faulkner
Jamaica Plain, Massachusetts, 02130
Dialysis Clinic Inc - East Cooper
Mt. Pleasant, South Carolina, 29464
Dialysis Clinic Inc - Azalea Place
North Charleston, South Carolina, 29406
Dialysis Clinic Inc - Oakland
Pittsburgh, Pennsylvania, 15213
Dialysis Clinic Inc - Banksville
Pittsburgh, Pennsylvania, 15216
Dialysis Clinic Inc - Point Breeze
Pittsburgh, Pennsylvania, 15221
Dialysis Clinic Inc - North Hills
Pittsburgh, Pennsylvania, 15237
Dialysis Clinic Inc - Rio Rancho
Rio Rancho, New Mexico, 87124
Dialysis Clinic Inc - Somerville
Somerville, Massachusetts, 02145
About this study
Official title: Blood Pressure in Dialysis Patients (BID Study)
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.
Read the detailed description
Mortality and morbidity among hemodialysis (HD) patients remain unacceptably high, thus there is a compelling need to improve clinical outcomes. Accordingly, the National Kidney Foundation's Kidney Disease Outcome Quality Improvement program (KDOQI) has published a guideline calling for a pre-dialysis systolic blood pressure (SBP) <140 mmHg in HD patients. However, the evidence supporting this guideline was graded as weak since it was largely extrapolated from the general population. Studies in the general population have demonstrated a continuous reduction in cardiovascular risk with each mmHg drop in systolic blood pressure (SBP), extending below levels that were in past considered "normal". The Systolic Blood Pressure Intervention Trial (SPRINT) study has showed a decrease in the composite outcome of CV events and CV mortality among non-diabetic patients at high risk for cardiovascular events by targeting a SBP of <120 mmHg. It is reasonable to postulate that intensive control of BP may be beneficial in HD patients, who in many ways resemble patients in SPRINT except that they have progressed to end stage renal disease. Thus, it is timely to propose conducting a RCT of intensive versus standard control of blood pressure in HD patients.
The investigators recognize that from observational studies suggest that mortality among HD patients may be increased among patients who meet the current KDOQI guideline. Unidentified confounders may have contributed to these surprising findings. The conclusions reached by observational studies in HD patients have often been refuted by randomized controlled trials (RCTs). Therefore, a RCT is needed to determine if a pre-dialysis SBP <140 mmHg specified by KDOQI is an appropriate target. Prior to beginning a full-scale-RCT, it is imperative to conduct a pilot study to demonstrate safety and efficacy and to inform the design of the full-scale study. The pilot study is designed to answer the following questions:
- What are the estimated recruitment, accrual and retention rates?
- What proportions of patients in each arm will achieve and maintain SBP within the assigned target and will the investigators achieve equal or greater than 10mmHg separation in the average SBP between the two arms?
- What are the anticipated adverse and serious adverse events rates within the intensive and standard arms?
- What end points should be used in the full-scale trial?
- What blood pressure (BP) measurements e.g., routine dialysis unit BP (RDUBPM), standardized dialysis unit BP (SDUBPM), standardized home BP (HBPM) or ambulatory BP monitoring (ABPM) to guide therapy? Although SDUBPM, HBPM and ABPM may be more powerful than RDUBP in predicting clinical outcomes,long term adherence with these techniques has not been demonstrated.
Specific Aims
- Establish procedures for SDUBPM, HBPM and ABPM and web-based data entry.
- Recruit and randomize patients into two treatment arms with target pre-dialysis SDUSBPM values <140 and < 160 mmHg and measure recruitment, accrual, and dropout rates in each arm.
- Assess the feasibility of attaining and maintaining these targets and the degree of SBP separation achieved during a one year intervention.
- Measure adherence rates for obtaining protocol SDUBPM, HBPM and ABPM over the one-year intervention.
- Assess the safety of treating participants to the study's SBP targets by measuring occurrence rates of CVD and non-CVD morbidity and mortality and other adverse and serious adverse events in each arm.
- Compare the differences in changes in left ventricular mass index (LVMI), aortic pulse wave velocity(APWV), and aortic distensibility, respectively, between the two study arms.
- Conduct statistical analyses to inform the design of the full-scale study.
- Being tested
- Antihypertensive Agents, Dry weight Challenge, Extend dialysis treatment time and re-challenge estimated dry weight
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist.
ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator
Dry weight ChallengeOther
Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal
Extend dialysis treatment time and re-challenge estimated dry weightDietary supplement
Extend dialysis treatment time and re-challenge estimated dry weight
| Study group | Role | What they receive |
|---|---|---|
| Treatment to an intensive BP goal | Active comparator | Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg Receives: Drug: Antihypertensive Agents; Other: Dry weight Challenge; Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight |
| Treatment to standard BP goal | Placebo comparator | Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg Receives: Drug: Antihypertensive Agents; Other: Dry weight Challenge; Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal
Measured: one year
Secondary outcomes (1)
Number or Participants Assessed for Change in LV Mass
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2016
- Study completionJun 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Medical University of South Carolina, University of Pittsburgh Medical Center, The Cleveland Clinic, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Philip Zager, MD, Study chair, University New MexicoDana Miskulin, PhD, Principal investigator, Tufts Medical CenterJennifer Gassman, MD, Principal investigator, The Cleveland ClinicDavid Ploth, MD, Principal investigator, Medical University of South CarolinaManisha Jhamb, Principal investigator, University of PittsburghMahboob Rahman, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421771
- Sponsor's protocol ID
- 1R01DK083424-01A1
- Acronym
- BID
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2011
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Miskulin DC, Gassman J, Schrader R, Gul A, Jhamb M, Ploth DW, Negrea L, Kwong RY, Levey AS, Singh AK, Harford A, Paine S, Kendrick C, Rahman M, Zager P. BP in Dialysis: Results of a Pilot Study. J Am Soc Nephrol. 2018 Jan;29(1):307-316. doi: 10.1681/ASN.2017020135. Epub 2017 Dec 6.
PubMed 29212839
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure in Dialysis Patients (BID Study)
- ClinicalTrials.gov ID
- NCT01421771
- Acronym / sponsor ID
- BID / 1R01DK083424-01A1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Medical University of South Carolina, University of Pittsburgh Medical Center, The Cleveland Clinic, Case Western Reserve University
- Study start
- Oct 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.
Detailed description
Mortality and morbidity among hemodialysis (HD) patients remain unacceptably high, thus there is a compelling need to improve clinical outcomes. Accordingly, the National Kidney Foundation's Kidney Disease Outcome Quality Improvement program (KDOQI) has published a guideline calling for a pre-dialysis systolic blood pressure (SBP) <140 mmHg in HD patients. However, the evidence supporting this guideline was graded as weak since it was largely extrapolated from the general population. Studies in the general population have demonstrated a continuous reduction in cardiovascular risk with each mmHg drop in systolic blood pressure (SBP), extending below levels that were in past considered "normal". The Systolic Blood Pressure Intervention Trial (SPRINT) study has showed a decrease in the composite outcome of CV events and CV mortality among non-diabetic patients at high risk for cardiovascular events by targeting a SBP of <120 mmHg. It is reasonable to postulate that intensive control of BP may be beneficial in HD patients, who in many ways resemble patients in SPRINT except that they have progressed to end stage renal disease. Thus, it is timely to propose conducting a RCT of intensive versus standard control of blood pressure in HD patients.
The investigators recognize that from observational studies suggest that mortality among HD patients may be increased among patients who meet the current KDOQI guideline. Unidentified confounders may have contributed to these surprising findings. The conclusions reached by observational studies in HD patients have often been refuted by randomized controlled trials (RCTs). Therefore, a RCT is needed to determine if a pre-dialysis SBP <140 mmHg specified by KDOQI is an appropriate target. Prior to beginning a full-scale-RCT, it is imperative to conduct a pilot study to demonstrate safety and efficacy and to inform the design of the full-scale study. The pilot study is designed to answer the following questions:
- What are the estimated recruitment, accrual and retention rates?
- What proportions of patients in each arm will achieve and maintain SBP within the assigned target and will the investigators achieve equal or greater than 10mmHg separation in the average SBP between the two arms?
- What are the anticipated adverse and serious adverse events rates within the intensive and standard arms?
- What end points should be used in the full-scale trial?
- What blood pressure (BP) measurements e.g., routine dialysis unit BP (RDUBPM), standardized dialysis unit BP (SDUBPM), standardized home BP (HBPM) or ambulatory BP monitoring (ABPM) to guide therapy? Although SDUBPM, HBPM and ABPM may be more powerful than RDUBP in predicting clinical outcomes,long term adherence with these techniques has not been demonstrated.
Specific Aims
- Establish procedures for SDUBPM, HBPM and ABPM and web-based data entry.
- Recruit and randomize patients into two treatment arms with target pre-dialysis SDUSBPM values <140 and < 160 mmHg and measure recruitment, accrual, and dropout rates in each arm.
- Assess the feasibility of attaining and maintaining these targets and the degree of SBP separation achieved during a one year intervention.
- Measure adherence rates for obtaining protocol SDUBPM, HBPM and ABPM over the one-year intervention.
- Assess the safety of treating participants to the study's SBP targets by measuring occurrence rates of CVD and non-CVD morbidity and mortality and other adverse and serious adverse events in each arm.
- Compare the differences in changes in left ventricular mass index (LVMI), aortic pulse wave velocity(APWV), and aortic distensibility, respectively, between the two study arms.
- Conduct statistical analyses to inform the design of the full-scale study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment to an intensive BP goal | Active comparator | Drug: Antihypertensive Agents, Other: Dry weight Challenge, Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weightTreatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg |
| Treatment to standard BP goal | Placebo comparator | Drug: Antihypertensive Agents, Other: Dry weight Challenge, Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weightTreatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- On thrice weekly maintenance hemodialysis for greater than 90 days
- For entry into baseline period: 2-week average RDUSBPM > 155 mm Hg on AHT medications or < 155 mm Hg on ≥ 1 AHT medications For randomization: 2-week average SDUSBPM ≥ 155 mm Hg
Key exclusion criteria (24 listed)
- Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
- Inability to measure blood pressures in an upper arm;
- History of inter or post-dialytic hypotension (defined as systolic blood pressure <90 mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring hospitalization (including emergency room visit) and/or the use of midodrine in the past 6 months;
- Required one or more urgent, unscheduled dialysis treatment for congestive heart failure in the past 3 months (other than in an incident patient at the time of starting dialysis);
- Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
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 |
|---|---|---|
| Antihypertensive AgentsStudy formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator | Drug | Treatment to an intensive BP goal, Treatment to standard BP goal |
| Dry weight ChallengeReduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal | Other | Treatment to an intensive BP goal, Treatment to standard BP goal |
| Extend dialysis treatment time and re-challenge estimated dry weightExtend dialysis treatment time and re-challenge estimated dry weight | Dietary supplement | Treatment to an intensive BP goal, Treatment to standard BP goal |
Primary outcome
Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal
Time frame: one year
1 secondary outcome
Number or Participants Assessed for Change in LV Mass
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29212839Miskulin DC, Gassman J, Schrader R, Gul A, Jhamb M, Ploth DW, Negrea L, Kwong RY, Levey AS, Singh AK, Harford A, Paine S, Kendrick C, Rahman M, Zager P. BP in Dialysis: Results of a Pilot Study. J Am Soc Nephrol. 2018 Jan;29(1):307-316. doi: 10.1681/ASN.2017020135. Epub 2017 Dec 6.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Philip Zager, MD study chair
University New Mexico
Dana Miskulin, PhD principal investigator
Tufts Medical Center
Jennifer Gassman, MD principal investigator
The Cleveland Clinic
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antihypertensive Agents, Dry weight Challenge and Extend dialysis treatment time and re-challenge estimated dry weight in people with Hypertension and Renal Failure Chronic Requiring Hemodialysis, run by University of New Mexico at 21 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 3 inclusion and 24 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 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?
Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal (time frame: one year). 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 NCT01421771, which also lists 1 linked publication.
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 30 Nov 2023.