An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-12-31

Brief Summary

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The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.

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Detailed Description

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Conditions

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Uncontrolled Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study Group

Study Group intervention: Therapeutic drug monitoring.

Group Type EXPERIMENTAL

Therapeutic drug monitoring

Intervention Type DIAGNOSTIC_TEST

Therapeutic drug monitoring will be performed.

Control Group

Control Group intervention: No intervention first 3 months. After 3 months of follow-up, half of the patients in the Control Group will be randomized to perform home blood pressure monitoring as an intervention. No intervention in the other half.

Group Type ACTIVE_COMPARATOR

Home blood pressure monitoring

Intervention Type DEVICE

Patients will perform home blood pressure monitoring at home.

Interventions

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Therapeutic drug monitoring

Therapeutic drug monitoring will be performed.

Intervention Type DIAGNOSTIC_TEST

Home blood pressure monitoring

Patients will perform home blood pressure monitoring at home.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Uncontrolled hypertension
* A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
* No planned changes in antihypertensive drugs

Exclusion Criteria

* Withdrawal of consent
* 24-h systolic ambulatory blood pressure \>/= 170 mmHg
* Patients with inadequate Norwegian language skills
* Positive pregnancy test
* Known alcohol or drug abuse
* estimated glomerular filtration rate \<30 mL/min/1.73m2
* Albumin/creatinin ratio \>300 mg/mmol
* Any reason why, in the opinion of the investigator, the patient should not participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No