ESRDTAKE-HOLDNCT03327909
Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
A study testing TAKE vs. HOLD in people with ESRD and Hemodialysis Complication, run by Stanford University at 2 sites in United States.
Trial summary
For patients with kidney failure requiring hemodialysis treatment, sometimes the blood pressure will drop too low during dialysis. In an effort to prevent that from occurring, patients are frequently told to skip doses of their blood pressure medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD, Hemodialysis Complication, Blood Pressure
- What is being tested?
- TAKE vs. HOLD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2018to 14 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 in-center thrice weekly hemodialysis
- Dialysis start time in the morning
- Taking at least one antihypertensive medication
Who cannot join
- Initiation of hemodialysis within previous 90 days
- Inability to provide informed consent
- Currently participating in another clinical trial (intervention study)
- >2 unexcused missed dialysis sessions in the previous 30 days
- Documented heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
- Cardiovascular event (e.g. myocardial infarction, stroke, heart failure) or procedure (e.g., coronary artery bypass, peripheral arterial bypass grafting, carotid artery procedures, aortic procedures) or hospitalization for unstable angina within the previous 90 days
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- End-stage liver disease
- Planned kidney transplant within the next 90 days
- Planned dialysis modality switch (to home hemodialysis, peritoneal dialysis, nocturnal hemodialysis) within the next 90 days
- Pregnancy, currently trying to become pregnant
- Active infection requiring antibiotic, antifungal or antiviral therapies
- Any factors judged by the treatment team to be likely to limit adherence to the interventions
- Active alcohol or substance abuse within the last 12 months
- Plans to move outside of the treatment area within in the next 90 days
- Other medical, psychiatric, or behavioral factors that in the judgement of the study team may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Satellite Health Care
Menlo Park, California, 94025
Satellite Health Care
San Carlos, California, 94070
About this study
For patients with kidney failure requiring hemodialysis treatment, sometimes the blood pressure will drop too low during dialysis. In an effort to prevent that from occurring, patients are frequently told to skip doses of their blood pressure medications. However, whether this actually prevents blood pressure drops during dialysis, and whether it may cause more uncontrolled high blood pressure is unknown. TAKE-HOLD will study the effect of taking or holding blood pressure medication on blood pressure for patients on hemodialysis.
Read the detailed description
High blood pressure (BP) is a major modifiable risk factor for cardiovascular disease, and upwards of 90% of patients with end- stage renal disease (ESRD) have high BP. Appropriate BP management, therefore, is a fundamental part of patient care in ESRD, yet the question of when best to take antihypertensive medications relative to the hemodialysis treatment session remains unanswered. Many patients on hemodialysis suffer from an abrupt fall in BP during the dialysis session (i.e., intradialytic hypotension [IDH]), a phenomenon that is associated with numerous adverse outcomes. In an attempt to minimize IDH, patients are often told to withhold antihypertensive medications prior to hemodialysis, and current guidelines suggest taking antihypertensive medications at night to minimize IDH. However, there are no data regarding the safety of these antihypertensive medication timing strategies, or whether these strategies are effective in reducing IDH.
- Conditions
- ESRD, Hemodialysis Complication, Blood Pressure
- Being tested
- TAKE vs. HOLD
- Keywords
- Intradialytic Hypotension, Hypertension, Ambulatory Blood Pressure
- Medical subject headings
- Kidney Failure, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAKE vs. HOLDBehavioural
All participants will be told to take once daily antihypertensive medications at night. Timing of other antihypertensive medication administration will differ depending on whether the participant is randomized to the TAKE or HOLD arm.
| Study group | Role | What they receive |
|---|---|---|
| TAKE | Experimental | Participants in TAKE units will be advised to take all antihypertensive medications as prescribed, including on the morning of dialysis. Receives: Behavioral: TAKE vs. HOLD |
| HOLD | Experimental | Participants in the HOLD units will advised to hold the dose of the antihypertensive medications prior to the dialysis session on the morning of the dialysis days. Participants can choose whether they wish to take the antihypertensive medication that was held at any time after the dialysis session has ended. Receives: Behavioral: TAKE vs. HOLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic Hypotension
Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.
Measured: 4-week intervention period
Secondary outcomes (2)
Poorly controlled pre-dialysis blood pressure
Number of participants with ≥30% of dialysis sessions with pre-dialysis systolic BP > 160 mm Hg
Measured: 4-week intervention period
Dialysis Tolerability
Number of participants with ≥30% of dialysis sessions with post-dialysis weight > prescribed dry weight or delivered length of dialysis < prescribed length. We will also assess dialysis symptoms using the Dialysis Symptom Index.
Measured: 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start16 Jul 2018
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized parallel group trial
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Healthcare
- Responsible party
- Principal investigator, Tara I-Hsin Chang, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327909
- Sponsor's protocol ID
- TAKE-HOLD
- Acronym
- TAKE-HOLD
- Status last verified
- Aug 2022
- First submitted
- 27 Oct 2017
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang TI, Tatoian ET, Montez-Rath ME, Chertow GM. Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis: A Cluster Randomized Trial. Kidney360. 2021 Sep 16;2(11):1752-1760. doi: 10.34067/KID.0001922021. eCollection 2021 Nov 25.
PubMed 35373003
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
- ClinicalTrials.gov ID
- NCT03327909
- Acronym / sponsor ID
- TAKE-HOLD / TAKE-HOLD
- Conditions
- ESRD, Hemodialysis Complication, Blood Pressure
- Keywords
- Intradialytic Hypotension, Hypertension, Ambulatory Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Satellite Healthcare
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients with kidney failure requiring hemodialysis treatment, sometimes the blood pressure will drop too low during dialysis. In an effort to prevent that from occurring, patients are frequently told to skip doses of their blood pressure medications. However, whether this actually prevents blood pressure drops during dialysis, and whether it may cause more uncontrolled high blood pressure is unknown. TAKE-HOLD will study the effect of taking or holding blood pressure medication on blood pressure for patients on hemodialysis.
Detailed description
High blood pressure (BP) is a major modifiable risk factor for cardiovascular disease, and upwards of 90% of patients with end- stage renal disease (ESRD) have high BP. Appropriate BP management, therefore, is a fundamental part of patient care in ESRD, yet the question of when best to take antihypertensive medications relative to the hemodialysis treatment session remains unanswered. Many patients on hemodialysis suffer from an abrupt fall in BP during the dialysis session (i.e., intradialytic hypotension [IDH]), a phenomenon that is associated with numerous adverse outcomes. In an attempt to minimize IDH, patients are often told to withhold antihypertensive medications prior to hemodialysis, and current guidelines suggest taking antihypertensive medications at night to minimize IDH. However, there are no data regarding the safety of these antihypertensive medication timing strategies, or whether these strategies are effective in reducing IDH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized parallel group trial
| Arm | Type | Receives |
|---|---|---|
| TAKE | Experimental | Behavioral: TAKE vs. HOLDParticipants in TAKE units will be advised to take all antihypertensive medications as prescribed, including on the morning of dialysis. |
| HOLD | Experimental | Behavioral: TAKE vs. HOLDParticipants in the HOLD units will advised to hold the dose of the antihypertensive medications prior to the dialysis session on the morning of the dialysis days. Participants can choose whether they wish to take the antihypertensive medication that was held at any time after the dialysis session has ended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- On in-center thrice weekly hemodialysis
- Dialysis start time in the morning
- Taking at least one antihypertensive medication
Key exclusion criteria (15 listed)
- Initiation of hemodialysis within previous 90 days
- Inability to provide informed consent
- Currently participating in another clinical trial (intervention study)
- >2 unexcused missed dialysis sessions in the previous 30 days
- Documented heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
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 |
|---|---|---|
| TAKE vs. HOLDAll participants will be told to take once daily antihypertensive medications at night. Timing of other antihypertensive medication administration will differ depending on whether the participant is randomized to the TAKE or HOLD arm. | Behavioural | HOLD, TAKE |
Primary outcome
Intradialytic Hypotension
Time frame: 4-week intervention period
Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.
2 secondary outcomes
Poorly controlled pre-dialysis blood pressure
Time frame: 4-week intervention period
Dialysis Tolerability
Time frame: 4-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 35373003Chang TI, Tatoian ET, Montez-Rath ME, Chertow GM. Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis: A Cluster Randomized Trial. Kidney360. 2021 Sep 16;2(11):1752-1760. doi: 10.34067/KID.0001922021. eCollection 2021 Nov 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAKE vs. HOLD in people with ESRD and Hemodialysis Complication, run by Stanford University 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 4 inclusion and 15 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 23 Aug 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intradialytic Hypotension (time frame: 4-week intervention period). 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 NCT03327909, 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 23 Aug 2022.