Clinical trial NCT02362893: Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control
Official title: Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Adherence
Direct Observed Therapy (DOT)
RCT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 24-hour ambulatory mean systolic daytime blood pressure
timeFrame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
Secondary outcomes:
measure: Change in mean office systolic blood pressure
timeFrame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Aud Høieggen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Hoieggen A. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013 Sep;62(3):526-32. doi: 10.1161/HYPERTENSIONAHA.113.01452. Epub 2013 Jul 8.
citation: Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Hoieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014 May;63(5):991-9. doi: 10.1161/HYPERTENSIONAHA.114.03246. Epub 2014 Mar 3.