An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment
IDA
Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 25, 2025
March 1, 2025
5.2 years
July 4, 2017
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure control
Change in systolic daytime ambulatory blood pressure.
3 months after baseline
Study Arms (2)
Study Group
EXPERIMENTALStudy Group intervention: Therapeutic drug monitoring.
Control Group
ACTIVE COMPARATORControl 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.
Interventions
Patients will perform home blood pressure monitoring at home.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Uncontrolled hypertension
- A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
- No planned changes in antihypertensive drugs
You may not qualify if:
- Withdrawal of consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
- Haukeland University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- St. Olavs Hospitalcollaborator
Study Sites (1)
Oslo University Hospital
Oslo, 0424, Norway
Related Publications (5)
Rognstad S, Soraas CL, Brunborg C, Halvorsen LV, Brobak KM, Olsen E, Bergland OU, Aune A, Tuv SS, Svarstad AC, Clasen PE, Haldsrud R, Larstorp ACK, Helland A, Opdal MS. Pharmacokinetic Variability of Amlodipine Serum Concentration and Effect on Blood Pressure in Patients Treated for Hypertension. Pharmacol Res Perspect. 2025 Aug;13(4):e70140. doi: 10.1002/prp2.70140.
PMID: 40616336DERIVEDHalvorsen LV, Soraas CL, Larstorp ACK, Hjornholm U, Kjaer VN, Liestol K, Aune A, Olsen E, Brobak KM, Bergland OU, Rognstad S, Aarskog NR, Heimark S, Fadl Elmula FEM, Gerdts E, Mo R, Solbu MD, Opdal MS, Kjeldsen SE, Rostrup M, Hoieggen A. Effect of Therapeutic Drug Monitoring on Adherence and Blood Pressure: A Multicenter Randomized Clinical Trial. Am J Hypertens. 2024 Sep 16;37(10):826-836. doi: 10.1093/ajh/hpae059.
PMID: 38713475DERIVEDBrobak KM, Halvorsen LV, Aass HCD, Soraas CL, Aune A, Olsen E, Bergland OU, Rognstad S, Blom KB, Birkeland JAK, Hoieggen A, Larstorp ACK, Solbu MD. Novel biomarkers in patients with uncontrolled hypertension with and without kidney damage. Blood Press. 2024 Dec;33(1):2323980. doi: 10.1080/08037051.2024.2323980. Epub 2024 Apr 12.
PMID: 38606688DERIVEDAune A, Ohldieck A, Halvorsen LV, Brobak KM, Olsen E, Rognstad S, Larstorp ACK, Soraas CL, Rossebo AB, Rosner A, Grytaas MA, Gerdts E. Gender Differences in Cardiac Organ Damage in Arterial Hypertension: Assessing the Role of Drug Nonadherence. High Blood Press Cardiovasc Prev. 2024 Mar;31(2):157-166. doi: 10.1007/s40292-024-00632-6. Epub 2024 Mar 26.
PMID: 38530572DERIVEDBergland 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.
PMID: 34275336DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sverre E Kjeldsen, MD PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 6, 2017
Study Start
November 1, 2017
Primary Completion
December 31, 2022
Study Completion
December 31, 2025
Last Updated
March 25, 2025
Record last verified: 2025-03