Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
| Registry | NCT03209154, acronym IDA |
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| Status | Active not recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, prevention |
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| Enrollment | 1000 (Estimated) |
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| Sponsor | Oslo University Hospital (Other); collaborators: University of Oslo, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital |
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| Conditions | Uncontrolled Hypertension |
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| Interventions | Therapeutic drug monitoring, Home blood pressure monitoring (Diagnostic test, device) |
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| Dates | start 2017-11-01, primary completion 2022-12-31, completion 2025-12-31 (estimated), first posted 2017-07-06, last updated 2025-03-25 |
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| Locations | 1 site in Norway |
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Related Papers Related Patents Related Grants Related Experts
All trials for Uncontrolled Hypertension All trials of Therapeutic drug monitoring All trials of Home blood pressure monitoring
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Study Group | Experimental | Diagnostic Test: Therapeutic drug monitoring | Study Group intervention: Therapeutic drug monitoring. |
| Control Group | Active comparator | Device: 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. |
- Therapeutic drug monitoring (Diagnostic test): Therapeutic drug monitoring will be performed.
- Home blood pressure monitoring (Device): Patients will perform home blood pressure monitoring at home.
+Outcome measures
Primary outcomes
- Blood pressure control [3 months after baseline]: Change in systolic daytime ambulatory blood pressure.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Oslo University Hospital | Oslo | Norway | |
+Publications
- Results publication: 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 40616336
- Results publication: Halvorsen 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 38713475
- Results publication: Brobak 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 38606688
- Results publication: Aune 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 38530572
- Results publication: 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. PMID 34275336
+Investigators