Coronary Artery DiseaseHeartCheckNCT07720349
Digital Long-term Follow-up of Patients With Coronary Artery Disease
A study testing "HeartCheck" in people with Coronary Artery Disease, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- "HeartCheck"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Apr 2026to Dec 2029
- 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
- >18 years of age
- survived a recent (<30 days) AMI and/or PCI
- access to a smartphone or tablet
- signed written informed consent
Who cannot join
- patient does not understand Norwegian
- patient is unable to comply with the study procedures due to severe comorbidities or high age
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ida O Nilsen contact
Norway2 sites, 2 recruiting
- Recruiting
Sørlandet Hospital Arendal
Arendal
Jarle Jortveit, +4799450714, jarle.jortveit@gmail.com
- Recruiting
Oslo University Hospital Ullevål
Oslo
Sigrun Halvorsen Halvorsen, +4722119101, sigruha@uio.no
Ida O Nilsen
About this study
Official title: Digital Long-term Follow-up of Patients With Coronary Artery Disease: a Randomized Controlled Trial
The need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up after AMI. The overall goal of the digital solution is to increase knowledge and awareness about important lifestyle measures and CV risk factors in patients who have survived an AMI, and to make it easy for the patients to monitor their own risk factors and attainment of treatment goals during long-term follow-up. Further, the HeartCheck seeks to provide guidance to ensure medication adherence. In this project, we study whether this newly developed app (HeartCheck), through education, regular reminders and easily understandable goals for secondary prevention, can improve risk factor control and drug adherence during long-term follow-up after AMI. A randomized controlled trial (RCT) is the chosen study design, being the gold standard for testing effectiveness of interventions.
- Conditions
- Coronary Artery Disease
- Being tested
- "HeartCheck"
- Keywords
- coronary artery disease, secondary prevention, digital application
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HeartCheck"Device
a digital application developed specifically for patient support during follow-up after acute myocardial infarction or PI for stable coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Use of a digital application for follow-up | Experimental | Use of the application "Heart-Check" developed by the researchers Receives: Device: "HeartCheck" |
| Usual care | No intervention | Patients are offered standard followed up by their hospital and GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients fulfilling 4 evidence-based goals for risk factor control
Proportion of patients who fulfills all of the following: 1) BP <130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c <53mmol/mol, 4) No smoking
Measured: 12 months after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Responsible party
- Principal investigator, Sigrun Halvorsen, Oslo University Hospital
- Investigators
- Sigrun Halvorsen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720349
- Sponsor's protocol ID
- 25/07916
- Acronym
- HeartCheck
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Long-term Follow-up of Patients With Coronary Artery Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07720349
- Acronym / sponsor ID
- HeartCheck / 25/07916
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, secondary prevention, digital application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jul 2026 (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 need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up after AMI. The overall goal of the digital solution is to increase knowledge and awareness about important lifestyle measures and CV risk factors in patients who have survived an AMI, and to make it easy for the patients to monitor their own risk factors and attainment of treatment goals during long-term follow-up. Further, the HeartCheck seeks to provide guidance to ensure medication adherence. In this project, we study whether this newly developed app (HeartCheck), through education, regular reminders and easily understandable goals for secondary prevention, can improve risk factor control and drug adherence during long-term follow-up after AMI. A randomized controlled trial (RCT) is the chosen study design, being the gold standard for testing effectiveness of interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a digital application for follow-up | Experimental | Device: "HeartCheck"Use of the application "Heart-Check" developed by the researchers |
| Usual care | No intervention | –Patients are offered standard followed up by their hospital and GP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- survived a recent (<30 days) AMI and/or PCI
- access to a smartphone or tablet
- signed written informed consent
Key exclusion criteria (2 listed)
- patient does not understand Norwegian
- patient is unable to comply with the study procedures due to severe comorbidities or high age
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 |
|---|---|---|
| "HeartCheck"a digital application developed specifically for patient support during follow-up after acute myocardial infarction or PI for stable coronary artery disease | Device | Use of a digital application for follow-up |
Primary outcome
Proportion of patients fulfilling 4 evidence-based goals for risk factor control
Time frame: 12 months after inclusion in the study
Proportion of patients who fulfills all of the following: 1) BP <130/80 mmHg, 2) LDL-cholesterol <1.4 mmol/l, 3) HbA1c <53mmol/mol, 4) No smoking
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 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ida O Nilsen contact
Sigrun Halvorsen principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "HeartCheck" in people with Coronary Artery Disease, run by Oslo University Hospital at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Sigrun Halvorsen (+4722119101, sigruha@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients fulfilling 4 evidence-based goals for risk factor control (time frame: 12 months after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.