Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control

Oslo University Hospital20 enrolled

Overview

The purpose of the study is to access the change in mean daytime systolic blood pressure in participants with essential hypertension not adequately controlled (defined as mean systolic daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a control group with standard ABPM.

More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT. Estimated \< 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment. Poor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives. In a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Direct Observed TherapyOTHER

Patients allocated to the intervention group take their medication (from original blister packaged) in front of the invistigator who observe the patient swallowing the medication. To secure the principals of Direct Observed Therapy, the patient do not leave the clinic for two hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years and above * Residing in Oslo/Akershus * Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg * ≥ 2 antihypertensive medications * Be able to read and write Norwegian Exclusion Criteria: * Critical illness, ongoing treatment * Known atrial fibrillation * Known heart valve stenosis * Myocardial infarction, angina pectoris or stroke the past 6 months * Known severe renal impairment (eGFR \< 30 ml/min/1.73 m2) * History of DOT prior to ABPM * Participation in other interventional study

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Change in 24-hour ambulatory mean systolic daytime blood pressure

Time frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Secondary Outcomes

Change in mean office systolic blood pressure

Time frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Data from ClinicalTrials.gov

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