Out-Of-Hospital Cardiac ArrestNCT03835403
The HeartRunner Trial
A study testing Activation of HeartRunners in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Activation of HeartRunners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,114 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2019to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
- Non-traumatic etiology, this excludes intoxication, drowning or suicide.
- Age > 7 years
Who cannot join
- Caller is not in direct contact with the patient
- If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
- OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
- OHCAs with no heart runners within 1800 meters
- Not true cardiac arrest (suspected, but not verified)
- EMS-witnessed OHCAs
- Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.
- These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.
Read the detailed description
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (< 3 min, 3-9 min, > 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Activation of HeartRunners
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of HeartRunnersOther
Activation of volunteer citizen first-responders to respond to nearby cardiac arrests
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (control arm) | No intervention | These cardiac arrests will receive standard EMS response. |
| HeartRunner Activation | Experimental | For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response. Receives: Other: Activation of HeartRunners |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day survival
Patient alive 30 days after date of out-of-hospital cardiac arrest
Measured: 30 days after date of out-of-hospital cardiac arrest
Secondary outcomes (5)
Rates of bystander defibrillation
Percentage of patients who received defibrillation prior to EMS arrival
Measured: During cardiac arrest
Rates of bystander cardiopulmonary resuscitation
Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
Measured: During cardiac arrest
Rates of return of spontaneuous circulation
sustained circulation indicating successful resuscitation
Measured: Immediately after out-of-hospital cardiac arrest
Rates of survival after 1 year
percentage of patients alive 1 year after out-of-hospital cardiac arrest
Measured: 1 year after date of out-of-hospital cardiac arrest
Rates of neurological intact survival
percentage of patients with cerebral performance category score of 1-2
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start15 May 2019
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Fredrik Folke, Emergency Medical Services, Capital Region, Denmark
- Investigators
- Fredrik Folke, MD, PhD, Principal investigator, Copenhagen EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835403
- Sponsor's protocol ID
- The HeartRunner Trial
- Status last verified
- May 2026
- First submitted
- 7 Feb 2019
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folke F, Andelius L, Ersboll AK, Torp-Pedersen C, Gislason G, Kober L, Lippert F, Tofte Gregers MC, Shahriari P, Kjaerulf V, Malta Hansen C. Public access defibrillation by activated community first responders - the randomized HeartRunner trial. Resusc Plus. 2026 Jul 21;31:101420. doi: 10.1016/j.resplu.2026.101420. eCollection 2026 Sep.
PubMed 42630735Mottlau KH, Andelius LC, Gregersen R, Malta Hansen C, Folke F. Citizen Responder Activation in Out-of-Hospital Cardiac Arrest by Time of Day and Day of Week. J Am Heart Assoc. 2022 Feb;11(3):e023413. doi: 10.1161/JAHA.121.023413. Epub 2022 Jan 21.
PubMed 35060395Andelius L, Malta Hansen C, Lippert FK, Karlsson L, Torp-Pedersen C, Kjaer Ersboll A, Kober L, Collatz Christensen H, Blomberg SN, Gislason GH, Folke F. Smartphone Activation of Citizen Responders to Facilitate Defibrillation in Out-of-Hospital Cardiac Arrest. J Am Coll Cardiol. 2020 Jul 7;76(1):43-53. doi: 10.1016/j.jacc.2020.04.073.
PubMed 32616162
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
- ClinicalTrials.gov ID
- NCT03835403
- Acronym / sponsor ID
- The HeartRunner Trial
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,114 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- TrygFonden, Denmark
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 8 Feb 2019 (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 study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.
Detailed description
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (< 3 min, 3-9 min, > 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (control arm) | No intervention | –These cardiac arrests will receive standard EMS response. |
| HeartRunner Activation | Experimental | Other: Activation of HeartRunnersFor these cardiac arrests, HeartRunners will be activated in addition to standard EMS response. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
- Non-traumatic etiology, this excludes intoxication, drowning or suicide.
- Age > 7 years
Key exclusion criteria (8 listed)
- Caller is not in direct contact with the patient
- If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
- OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
- OHCAs with no heart runners within 1800 meters
- Not true cardiac arrest (suspected, but not verified)
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 |
|---|---|---|
| Activation of HeartRunnersActivation of volunteer citizen first-responders to respond to nearby cardiac arrests | Other | HeartRunner Activation |
Primary outcome
30-day survival
Time frame: 30 days after date of out-of-hospital cardiac arrest
Patient alive 30 days after date of out-of-hospital cardiac arrest
5 secondary outcomes
Rates of bystander defibrillation
Time frame: During cardiac arrest
Rates of bystander cardiopulmonary resuscitation
Time frame: During cardiac arrest
Rates of return of spontaneuous circulation
Time frame: Immediately after out-of-hospital cardiac arrest
Rates of survival after 1 year
Time frame: 1 year after date of out-of-hospital cardiac arrest
Rates of neurological intact survival
Time frame: At hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42630735Folke F, Andelius L, Ersboll AK, Torp-Pedersen C, Gislason G, Kober L, Lippert F, Tofte Gregers MC, Shahriari P, Kjaerulf V, Malta Hansen C. Public access defibrillation by activated community first responders - the randomized HeartRunner trial. Resusc Plus. 2026 Jul 21;31:101420. doi: 10.1016/j.resplu.2026.101420. eCollection 2026 Sep.
- Derived from this study: PubMed 35060395Mottlau KH, Andelius LC, Gregersen R, Malta Hansen C, Folke F. Citizen Responder Activation in Out-of-Hospital Cardiac Arrest by Time of Day and Day of Week. J Am Heart Assoc. 2022 Feb;11(3):e023413. doi: 10.1161/JAHA.121.023413. Epub 2022 Jan 21.
- Derived from this study: PubMed 32616162Andelius L, Malta Hansen C, Lippert FK, Karlsson L, Torp-Pedersen C, Kjaer Ersboll A, Kober L, Collatz Christensen H, Blomberg SN, Gislason GH, Folke F. Smartphone Activation of Citizen Responders to Facilitate Defibrillation in Out-of-Hospital Cardiac Arrest. J Am Coll Cardiol. 2020 Jul 7;76(1):43-53. doi: 10.1016/j.jacc.2020.04.073.
- 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. This study is not recruiting at the moment.
Fredrik Folke, MD, PhD principal investigator
Copenhagen EMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activation of HeartRunners in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 15 May 2026. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day survival (time frame: 30 days after date of out-of-hospital cardiac arrest). 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 NCT03835403, which also lists 3 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 15 May 2026.