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Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis (TAKE-HOLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327909
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Tara I-Hsin Chang, Stanford University

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE July 16, 2018
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Intradialytic Hypotension [ Time Frame: 4-week intervention period ]
Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • Poorly controlled pre-dialysis blood pressure [ Time Frame: 4-week intervention period ]
    Number of participants with ≥30% of dialysis sessions with pre-dialysis systolic BP > 160 mm Hg
  • Dialysis Tolerability [ Time Frame: 4-week intervention period ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2017)
44-hour ambulatory blood pressure [ Time Frame: Final week of the 4-week intervention period ]
Compare the number of hours spent in the desired systolic BP range of 110-150 mm Hg in patients in TAKE versus HOLD units. We will also compare the number of patients who demonstrate nocturnal dipping patterns of BP in the TAKE and HOLD units.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
Official Title  ICMJE Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster randomized parallel group trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • ESRD
  • Hemodialysis Complication
  • Blood Pressure
Intervention  ICMJE Behavioral: TAKE vs. HOLD
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 Arms  ICMJE
  • Experimental: TAKE
    Participants in TAKE units will be advised to take all antihypertensive medications as prescribed, including on the morning of dialysis.
    Intervention: Behavioral: TAKE vs. HOLD
  • Experimental: HOLD
    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.
    Intervention: Behavioral: TAKE vs. HOLD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2020)
131
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
500
Actual Study Completion Date  ICMJE December 14, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. On in-center thrice weekly hemodialysis
  3. Dialysis start time in the morning
  4. Taking at least one antihypertensive medication

Exclusion Criteria:

  1. Initiation of hemodialysis within previous 90 days
  2. Inability to provide informed consent
  3. Currently participating in another clinical trial (intervention study)
  4. >2 unexcused missed dialysis sessions in the previous 30 days
  5. Documented heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
  6. 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
  7. End-stage liver disease
  8. Planned kidney transplant within the next 90 days
  9. Planned dialysis modality switch (to home hemodialysis, peritoneal dialysis, nocturnal hemodialysis) within the next 90 days
  10. Pregnancy, currently trying to become pregnant
  11. Active infection requiring antibiotic, antifungal or antiviral therapies
  12. Any factors judged by the treatment team to be likely to limit adherence to the interventions

    1. Active alcohol or substance abuse within the last 12 months
    2. Plans to move outside of the treatment area within in the next 90 days
    3. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327909
Other Study ID Numbers  ICMJE TAKE-HOLD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tara I-Hsin Chang, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Satellite Healthcare
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP