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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02362893
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
Ulla Hjørnholm, 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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Direct Observed Therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control
Study Start Date : April 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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.
Other: Direct Observed Therapy
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.
Other Name: DOT

No Intervention: Control
Standard care

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in mean office systolic blood pressure [ Time Frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02362893

Contact: Aud Høieggen, MD PhD
Contact: Ulla P Hjørnholm, Bachelor

Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Aud Hoieggen, MD PhD   
Contact: Ulla P. Hjoernholm   
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Aud Høieggen, MD PhD Oslo University Hospital