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

Hypertension Clinical Trial

— DRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362893
• Other study ID #: 2015/159
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjønnæss E, Hjørnholm U, Kjær VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Høieggen 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. — View Citation

Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjønnæss E, Hjørnholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Høieggen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour ambulatory mean systolic daytime blood pressure		Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
Secondary	Change in mean office systolic blood pressure		Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.