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

NCT04826250 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

PROCEDURE

Timing of medication

Either morning or nighttime medication

Sponsors & Collaborators

  • Tel Aviv University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-04-15
Completion
2022-06-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826250 on ClinicalTrials.gov