An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

Not Applicable

Active, not recruiting

• Conditions: Uncontrolled Hypertension
• Interventions: Diagnostic Test: Therapeutic drug monitoring; Device: Home blood pressure monitoring

• Registration Number: NCT03209154
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Study Start: 2017-11-01
• Primary Completion: 2022-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Therapeutic drug monitoring	Study Group intervention: Therapeutic drug monitoring.
Control Group	Home blood pressure monitoring	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure control	3 months after baseline	Change in systolic daytime ambulatory blood pressure.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway