Uncontrolled HypertensionIDANCT03209154
An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment
A study testing Therapeutic drug monitoring and Home blood pressure monitoring in people with Uncontrolled Hypertension, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Therapeutic drug monitoring and Home blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Uncontrolled hypertension
- A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
- No planned changes in antihypertensive drugs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Therapeutic drug monitoring, Home blood pressure monitoring
- Keywords
- Adherence, Therapeutic Drug Monitoring, Patient perspective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic drug monitoringDiagnostic test
Therapeutic drug monitoring will be performed.
Home blood pressure monitoringDevice
Patients will perform home blood pressure monitoring at home.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Study Group intervention: Therapeutic drug monitoring. Receives: Diagnostic Test: Therapeutic drug monitoring |
| Control Group | Active comparator | 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. Receives: Device: Home blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Change in systolic daytime ambulatory blood pressure.
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Principal investigator, Sverre Erik Kjeldsen, Oslo University Hospital
- Investigators
- Sverre E Kjeldsen, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209154
- Sponsor's protocol ID
- 2017/6534
- Acronym
- IDA
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40616336Halvorsen 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.
PubMed 38713475Brobak 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.
PubMed 38606688Aune 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.
PubMed 38530572Bergland 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.
PubMed 34275336
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT03209154
- Acronym / sponsor ID
- IDA / 2017/6534
- Conditions
- Uncontrolled Hypertension
- Keywords
- Adherence, Therapeutic Drug Monitoring, Patient perspective
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Therapeutic drug monitoringStudy Group intervention: Therapeutic drug monitoring. |
| Control Group | Active comparator | Device: Home blood pressure monitoringControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Uncontrolled hypertension
- A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
- No planned changes in antihypertensive drugs
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic drug monitoringTherapeutic drug monitoring will be performed. | Diagnostic test | Study Group |
| Home blood pressure monitoringPatients will perform home blood pressure monitoring at home. | Device | Control Group |
Primary outcome
Blood pressure control
Time frame: 3 months after baseline
Change in systolic daytime ambulatory blood pressure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 40616336Rognstad 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.
- Derived from this study: PubMed 38713475Halvorsen 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.
- Derived from this study: PubMed 38606688Brobak 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.
- Derived from this study: PubMed 38530572Aune 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.
- Derived from this study: PubMed 34275336Bergland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sverre E Kjeldsen, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic drug monitoring and Home blood pressure monitoring in people with Uncontrolled Hypertension, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control (time frame: 3 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209154, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.