NCT02362893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

February 9, 2015

Last Update Submit

August 27, 2019

Conditions

Hypertension

Keywords

HypertensionAdherenceDirect Observed Therapy (DOT)RCT

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour ambulatory mean systolic daytime blood pressure

    Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Secondary Outcomes (1)

  • Change in mean office systolic blood pressure

    Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.

Study Arms (2)

Direct Observed Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard care

Interventions

Direct Observed TherapyOTHER

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.

Also known as: DOT
Direct Observed Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and above
  • Residing in Oslo/Akershus
  • Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg
  • ≥ 2 antihypertensive medications
  • Be able to read and write Norwegian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (2)

  • 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.

    PMID: 23836798BACKGROUND

  • 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.

    PMID: 24591332BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Aud Høieggen, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN MSc

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)