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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Direct Observed Therapy

• Registration Number: NCT02362893
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Study Start: 2015-04
• Primary Completion: 2018-07
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Observed Therapy	Direct Observed Therapy	Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour ambulatory mean systolic daytime blood pressure	Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Change in mean office systolic blood pressure	Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway