The Effect of Timing of Antihypertensive Medication on Diurnal Fluctuations in Blood Pressure Using a Wearable Sensor With Continuous Monitoring

NCT04826250 | Withdrawn

• 1 other identifier: ABPM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Minimal or absent of diurnal fluctuation in blood pressure, and specifically conditions in which BP values are elevated during the night compared to daytime (rather than "nighttime dipping"), are associated with higher rates of morbidity and all-cause mortality. However, there is a gap in the scientific literature as to the optimal, individualized, timing of administration of antihypertensive drugs to balance daytime/nighttime fluctuations in BP to reduce the risk for cardiovascular morbidity and all-cause mortality. To date, the most widely used method for semi-continuous, ambulatory monitoring of BP is a Holter, cuff-based monitor, which is cumbersome to use and therefore results in low patient compliance. Despite various attempts to overcome this problem, practical, patient-friendly methods for continuous BP monitoring throughout the day and night are currently not available. Thus, the main of this study was to investigate whether there is a differential effect of timing of administration of antihypertensive drugs on diurnal fluctuations in BP using a wearable, cuff-less sensor with continuous monitoring capabilities. It is hypothesized that evening medication will improve BP fluctuations throughout the day (e.g., allow nighttime dipping and prevent morning surges) to a greater extend than morning meditation in people with hypertension.

Conditions

Hypertension

Keywords

ambulatory blood pressure monitoring; diurnal fluctuations; cardiovascular risk; Hypertension; wireless monitoring

Outcome Measures

Primary Outcomes (6)

• Nighttime blood pressure

  blood pressure measured during the night

  Baseline

• Nighttime blood pressure

  blood pressure measured during the night

  At the end of the first four-week intervention

• Nighttime blood pressure

  blood pressure measured during the night

  At the end of the second four-week intervention

• morning blood pressure

  blood pressure measured during the morning hours

  Baseline

• morning blood pressure

  blood pressure measured during the morning hours

  At the end of the first four-week intervention

• morning blood pressure

  blood pressure measured during the morning hours

  At the end of the second four-week intervention

Secondary Outcomes (12)

• Blood Glucose

  Baseline

• Blood Glucose

  At the end of the first four-week intervention

• Blood Glucose

  At the end of the second four-week intervention

• Insulin

  Baseline

• Insulin

  At the end of the first four-week intervention

Study Arms (2)

Hypertensive patients - nighttime medication

EXPERIMENTAL

Hypertensive patients will be instructed to take their medication in the evening for four consecutive weeks. At the end of this period, participants will switch the timing of medication to the morning for four weeks.

Procedure: Timing of medication

Hypertensive patients - morning medication

EXPERIMENTAL

Hypertensive patients will be instructed to take their medication in the morning for four consecutive weeks. At the end of this period, participants will switch the timing of medication to the evening for four weeks.

Procedure: Timing of medication

Interventions

Timing of medication PROCEDURE

Either morning or nighttime medication

Hypertensive patients - morning medication; Hypertensive patients - nighttime medication

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension

You may not qualify if:

• hypertensive emergency
• Those taking more than 3 anti-hypertensive drugs
• congestive heart failure
• pregnancy
• renal failure

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: January 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: June 1, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

IL (1)