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

Stanford University

Status: Completed

Conditions: Hemodialysis Complication; ESRD; Blood Pressure

Treatments: Behavioral: TAKE vs. HOLD

Study type: Interventional

Funder types: Other

Identifiers

NCT03327909

TAKE-HOLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

131 participants in 2 patient groups

TAKE

Experimental group

Description:

Participants in TAKE units will be advised to take all antihypertensive medications as prescribed, including on the morning of dialysis.

Treatment:

Behavioral: TAKE vs. HOLD

HOLD

Experimental group

Description:

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.

Treatment:

Behavioral: TAKE vs. HOLD