An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment (IDA)

November 2, 2023 updated by: Sverre Erik Kjeldsen, Oslo University Hospital

Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Study Group intervention: Therapeutic drug monitoring.
Diagnostic test: Therapeutic drug monitoring
Therapeutic drug monitoring will be performed.
Active Comparator: 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.
Device: Home blood pressure monitoring
Patients will perform home blood pressure monitoring at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure control
Time Frame: 3 months after baseline
Change in systolic daytime ambulatory blood pressure.
3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
University Hospital of North Norway
Haukeland University Hospital
St. Olavs Hospital

Investigators

  • Principal Investigator: Sverre E Kjeldsen, MD PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/6534

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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