Clinical trial NCT03327909: Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
Official title: Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Hemodialysis Complication
Blood Pressure
Keywords: Intradialytic Hypotension, Hypertension, Ambulatory Blood Pressure
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Satellite Healthcare
First posted: 2017-11-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized parallel group trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intradialytic Hypotension
timeFrame: 4-week intervention period
Secondary outcomes:
measure: Poorly controlled pre-dialysis blood pressure
timeFrame: 4-week intervention period
measure: Dialysis Tolerability
timeFrame: 4-week intervention period
Other outcomes:
measure: 44-hour ambulatory blood pressure
timeFrame: Final week of the 4-week intervention period
Locations:
city: Menlo Park
country: United States
facility: Satellite Health Care
state: California
city: San Carlos
country: United States
facility: Satellite Health Care
state: California
Study officials:
References:
citation: 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.