- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362893
Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control (DRIVE)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway, 0407
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Standard care
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in 24-hour ambulatory mean systolic daytime blood pressure
Time Frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean office systolic blood pressure
Time Frame: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aud Høieggen, MD PhD, Oslo University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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