Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

Not Applicable

Completed

• Conditions: Blood Pressure; ESRD; Hemodialysis Complication
• Interventions: Behavioral: TAKE vs. HOLD

• Registration Number: NCT03327909
• Lead Sponsor: Stanford University

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 Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2018-07-16
• Primary Completion: 2019-12-14
• Study Completion: 2019-12-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intradialytic Hypotension	4-week intervention period	Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.

Secondary Outcome Measures

Name	Time	Method
Poorly controlled pre-dialysis blood pressure	4-week intervention period	Number of participants with ≥30% of dialysis sessions with pre-dialysis systolic BP \> 160 mm Hg
Dialysis Tolerability	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.

Trial Locations

Locations (1)

Satellite Health Care; 🇺🇸 San Carlos, California, United States