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IDA: An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03209154
Collaborator
University of Oslo (Other), Haukeland University Hospital (Other), University Hospital of North Norway (Other), St. Olavs Hospital (Other)
1,000
Enrollment
1
Location
2
Arms
89.9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Therapeutic drug monitoring
  • Device: Home blood pressure monitoring
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
Actual Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Blood pressure control [3 months after baseline]

    Change in systolic daytime ambulatory blood pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sverre Erik Kjeldsen, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT03209154
Other Study ID Numbers:
  • 2017/6534
First Posted:
Jul 6, 2017
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sverre Erik Kjeldsen, Professor, Oslo University Hospital
Adherence
Therapeutic Drug Monitoring
Patient perspective
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Sep 9, 2021