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The HeartRunner Trial

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ClinicalTrials.gov Identifier: NCT03835403
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : December 8, 2022
TrygFonden, Denmark
Information provided by (Responsible Party):
Fredrik Folke, Emergency Medical Services, Capital Region, Denmark

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.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Other: Activation of HeartRunners Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Rates of bystander defibrillation [ Time Frame: During cardiac arrest ]
    Percentage of patients who received defibrillation prior to EMS arrival

  2. Rates of bystander cardiopulmonary resuscitation [ Time Frame: During cardiac arrest ]
    Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival

  3. Rates of return of spontaneuous circulation [ Time Frame: Immediately after out-of-hospital cardiac arrest ]
    sustained circulation indicating successful resuscitation

  4. Rates of survival after 1 year [ Time Frame: 1 year after date of out-of-hospital cardiac arrest ]
    percentage of patients alive 1 year after out-of-hospital cardiac arrest

  5. Rates of neurological intact survival [ Time Frame: At hospital discharge ]
    percentage of patients with cerebral performance category score of 1-2

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835403

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Contact: Fredrik Folke, MD, PhD +45 28182978 ff@heart.dk
Contact: Carolina Malta Hansen, MD, PhD +4560126127 carolina.malta.hansen.01@regionh.dk

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Emergency Medical Services Copenhagen Recruiting
Copenhagen, Ballerup, Denmark
Contact: Carolina Malta Hansen, MD, PhD       carolina.malta.hansen.01@regionh.dk   
Principal Investigator: Fredrik Folke, MD, PhD         
Sub-Investigator: Linn C Andelius, MD         
Sponsors and Collaborators
Emergency Medical Services, Capital Region, Denmark
TrygFonden, Denmark
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Principal Investigator: Fredrik Folke, MD, PhD Copenhagen EMS
  Study Documents (Full-Text)

Documents provided by Fredrik Folke, Emergency Medical Services, Capital Region, Denmark:
Study Protocol: Changes to protocol  [PDF] December 3, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fredrik Folke, MD, PhD, Head of Research, Emergency Medical Services, Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03835403    
Other Study ID Numbers: The HeartRunner Trial
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Out-of-Hospital Cardiac Arrest
Heart Arrest
Heart Diseases
Cardiovascular Diseases