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The HeartRunner Trial

Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03835403
Enrollment
2114
Registered
2019-02-08
Start date
2019-05-15
Completion date
2026-03-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-Of-Hospital Cardiac Arrest

Brief 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. 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.

Interventions

OTHERActivation of HeartRunners

Activation of volunteer citizen first-responders to respond to nearby cardiac arrests

Sponsors

Emergency Medical Services, Capital Region, Denmark
Lead SponsorOTHER_GOV
TrygFonden, Denmark
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
30-day survival30 days after date of out-of-hospital cardiac arrestPatient alive 30 days after date of out-of-hospital cardiac arrest

Secondary

MeasureTime frameDescription
Rates of bystander defibrillationDuring cardiac arrestPercentage of patients who received defibrillation prior to EMS arrival
Rates of bystander cardiopulmonary resuscitationDuring cardiac arrestPercentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
Rates of return of spontaneuous circulationImmediately after out-of-hospital cardiac arrestsustained circulation indicating successful resuscitation
Rates of survival after 1 year1 year after date of out-of-hospital cardiac arrestpercentage of patients alive 1 year after out-of-hospital cardiac arrest
Rates of neurological intact survivalAt hospital dischargepercentage of patients with cerebral performance category score of 1-2

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORFredrik Folke, MD, PhD

Copenhagen EMS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026