Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

Blood Pressure Clinical Trial

— TAKE-HOLD  

Official title:

Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327909
• Other study ID #: TAKE-HOLD
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: December 14, 2019

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• ESRD
• Hemodialysis Complication

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Satellite Health Care	Menlo Park	California
United States	Satellite Health Care	San Carlos	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Satellite Healthcare

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	44-hour ambulatory blood pressure	Compare the number of hours spent in the desired systolic BP range of 110-150 mm Hg in patients in TAKE versus HOLD units. We will also compare the number of patients who demonstrate nocturnal dipping patterns of BP in the TAKE and HOLD units.	Final week of the 4-week intervention period
Primary	Intradialytic Hypotension	Number of participants with =30% of dialysis sessions with symptomatic or asymptomatic IDH.	4-week intervention period
Secondary	Poorly controlled pre-dialysis blood pressure	Number of participants with =30% of dialysis sessions with pre-dialysis systolic BP > 160 mm Hg	4-week intervention period
Secondary	Dialysis Tolerability	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.	4-week intervention period