Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

NCT ID: NCT03327909

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-12-14

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.

Conditions

ESRD; Hemodialysis Complication; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAKE

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

Group Type: EXPERIMENTAL

TAKE vs. HOLD

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

TAKE vs. HOLD

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satellite Healthcare

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Tara I-Hsin Chang

Assistant Professor of Medicine (Nephrology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Satellite Health Care

Menlo Park, California, United States

Satellite Health Care

San Carlos, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35373003 (View on PubMed)

Other Identifiers

TAKE-HOLD

Identifier Type: -

Identifier Source: org_study_id