search
Back to results

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

Primary Purpose

Uncontrolled Hypertension

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Therapeutic drug monitoring
Home blood pressure monitoring
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uncontrolled Hypertension focused on measuring Adherence, Therapeutic Drug Monitoring, Patient perspective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Study Group intervention: Therapeutic drug 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.

Outcomes

Primary Outcome Measures

Blood pressure control
Change in systolic daytime ambulatory blood pressure.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2017
Last Updated
October 12, 2022
Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03209154
Brief Title
An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment
Acronym
IDA
Official Title
Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension
Keywords
Adherence, Therapeutic Drug Monitoring, Patient perspective

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study Group intervention: Therapeutic drug monitoring.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Therapeutic drug monitoring
Intervention Description
Therapeutic drug monitoring will be performed.
Intervention Type
Device
Intervention Name(s)
Home blood pressure monitoring
Intervention Description
Patients will perform home blood pressure monitoring at home.
Primary Outcome Measure Information:
Title
Blood pressure control
Description
Change in systolic daytime ambulatory blood pressure.
Time Frame
3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre E Kjeldsen, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34275336
Citation
Bergland OU, Halvorsen LV, Soraas CL, Hjornholm U, Kjaer VN, Rognstad S, Brobak KM, Aune A, Olsen E, Fauchald YM, Heimark S, Thorstensen CW, Liestol K, Solbu MD, Gerdts E, Mo R, Rostrup M, Kjeldsen SE, Hoieggen A, Opdal MS, Larstorp ACK, Fadl Elmula FEM. Detection of Nonadherence to Antihypertensive Treatment by Measurements of Serum Drug Concentrations. Hypertension. 2021 Sep;78(3):617-628. doi: 10.1161/HYPERTENSIONAHA.121.17514. Epub 2021 Jul 19.
Results Reference
derived

Learn more about this trial

An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment

We'll reach out to this number within 24 hrs