Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

NCT03327909 | Completed

• 1 other identifier: TAKE-HOLD
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

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.

Conditions

ESRD; Hemodialysis Complication; Blood Pressure

Keywords

Intradialytic Hypotension, Hypertension, Ambulatory Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Intradialytic Hypotension

  Number of participants with ≥30% of dialysis sessions with symptomatic or asymptomatic IDH.

  4-week intervention period

Secondary Outcomes (2)

• Poorly controlled pre-dialysis blood pressure

  4-week intervention period

• Dialysis Tolerability

  4-week intervention period

Other Outcomes (1)

• 44-hour ambulatory blood pressure

  Final week of the 4-week intervention period

Study Arms (2)

TAKE

EXPERIMENTAL

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

Behavioral: TAKE vs. HOLD

HOLD

EXPERIMENTAL

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.

Behavioral: TAKE vs. HOLD

Interventions

TAKE vs. HOLD 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; TAKE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• On in-center thrice weekly hemodialysis
• Dialysis start time in the morning
• Taking at least one antihypertensive medication

You may not qualify if:

• Initiation of hemodialysis within previous 90 days
• Inability to provide informed consent
• Currently participating in another clinical trial (intervention study)
• \>2 unexcused missed dialysis sessions in the previous 30 days
• Documented heart failure with reduced ejection fraction (left ventricular ejection fraction \< 40%)
• 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
• End-stage liver disease
• Planned kidney transplant within the next 90 days
• Planned dialysis modality switch (to home hemodialysis, peritoneal dialysis, nocturnal hemodialysis) within the next 90 days
• Pregnancy, currently trying to become pregnant
• Active infection requiring antibiotic, antifungal or antiviral therapies
• Any factors judged by the treatment team to be likely to limit adherence to the interventions
• Active alcohol or substance abuse within the last 12 months
• Plans to move outside of the treatment area within in the next 90 days
• 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

Sponsors & Collaborators

• Stanford University: lead
• Satellite Healthcare: collaborator

Study Sites (2)

Satellite Health Care

Menlo Park, California, 94025, United States

Location

Satellite Health Care

San Carlos, California, 94070, United States

Location

Related Publications (1)

• 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.

  PMID: 35373003 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Nephrology)

Model Details: Cluster randomized parallel group trial

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 1, 2017
• Study Start: July 16, 2018
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)