The HeartRunner Trial

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.

Study Overview

• Status: Completed
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: Activation of HeartRunners

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 Type: Interventional
• Enrollment (Actual): 2114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Ballerup
    • Copenhagen, Ballerup, Denmark
      • Emergency Medical Services Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (control arm); These cardiac arrests will receive standard EMS response.
Experimental: HeartRunner Activation; For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.	Other: Activation of HeartRunners; Activation of volunteer citizen first-responders to respond to nearby cardiac arrests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day survival	Patient alive 30 days after date of out-of-hospital cardiac arrest	30 days after date of out-of-hospital cardiac arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of bystander defibrillation	Percentage of patients who received defibrillation prior to EMS arrival	During cardiac arrest
Rates of bystander cardiopulmonary resuscitation	Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival	During cardiac arrest
Rates of return of spontaneuous circulation	sustained circulation indicating successful resuscitation	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	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	At hospital discharge

Collaborators and Investigators

• Sponsor: Emergency Medical Services, Capital Region, Denmark
• Collaborators: TrygFonden, Denmark
• Investigators: Principal Investigator: Fredrik Folke, MD, PhD, Copenhagen EMS

Publications and helpful links

General Publications

• Mottlau 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.
• Andelius 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: The HeartRunner Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes