Idiopathic Ventricular FibrillationPhase 4RIME-IVFNCT07405229
MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
A Phase 4 study testing Beta-blocker treatment group in people with Idiopathic Ventricular Fibrillation and Cardiac Arrest, Out-Of-Hospital, run by Bo Gregers Winkel at 2 sites in Denmark.
Trial summary
A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Ventricular Fibrillation, Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Beta-blocker treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2018to 31 Dec 2035
- Phase
- Phase 4
- 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
- Resuscitated OHCA patients admitted to one of the participating hospitals.
- Age ≥18 years
- Suspected cardiac cause of cardiac arrest
Who cannot join
- OHCA patients
- With Ischemic heart disease.
- Obvious non-cardiac cause of cardiac arrest
- Congenital heart disease
- Do not speak or understand Danish
- Foreigners -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
The Heart Center, Rigshospitalet
Copenhagen, Dr., 2100
Bo G Winkel, MD, PhD, 35459759, bo.winkel@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense, 5000
Finn L Henriksen, MD
About this study
Official title: Investigation of RIsk Factors in Out-of-hospital-cardiac-arrest Patients, and MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Today, there is no uniform way of approaching prevention of recurrence in idiopathic ventricular fibrillation (IVF) patients, beside ICD implantation. Better reatment and risk stratification tools are needed Medical treatment in these patients has never been assessed systematically, but at least some patients with no apparent diagnosis are on betablocker treatment. It is not known if low-doselow dose betablocker treatment is beneficial in these patients.
This study investigates the effect of betablocker treatment to reduce arrhythmic burden in IVF patients.
Read more
No predictors for appropriate ICD therapy have been identified in patients with IVF. It is also explored if toxicological and/or genetic profiles, together with in depth machine learning simulation data on repolarization patterns from IVF-ECGs compared to controls, can be used as risk stratification tools.
Lastly, QOL in IVF patients and the impact of beta blocker treatment will be investigated.
- Being tested
- Beta-blocker treatment group
- Keywords
- Idiopathic Ventricular Fibrillation, IVF, cardiac arrest, beta-blocker, treatment, ventricular tachyarrhythmias, Risk markers, quality of life, QoL
- Medical subject headings
- Paroxysmal ventricular fibrillation, Out-of-Hospital Cardiac Arrest, Heart Arrest, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-blocker treatment groupDrug
The betablocker given to the patient will be prioritized: 1) A non-selective betablocker: Propranolol Retard 80 mg daily or Nadolol 40 mg daily OR 2) A selective betablocker: Atenolol 25 mg daily, Bisoprolol 2.5 mg daily or Metoprolol 50 mg.
| Study group | Role | What they receive |
|---|---|---|
| Beta-blocker | Active comparator | Not described Receives: Drug: Beta-blocker treatment group |
| No medication | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
First appropriate therapy by ICD or 3 years after discharge
Primary outcome will be either first appropriate therapy by ICD (anti tachycardia pacing or DC conversion), or aborted shock or non-sustained ventricualr fibrillation detected by the ICD, where the treating physician opts for a change in medication, or no therapy from the ICD 3 years after randomization, whichever comes first.
Measured: 3 years
Secondary outcomes (2)
Quality of Life at 3 months
Quality of life will be assessed by trained nurses. Focus will be on betablocker therapy and overall cognitive abilities after cardiac arrest. Patients will be assessed using the SF-36 (v1) quality of life tool. The patients will be assessed 3 months after discharge.
Measured: 3 months
Quality of Life at 1 year
Quality of life will be assessed by trained nurses. Focus will be on betablocker therapy and overall cognitive abilities after cardiac arrest. Patients will be assessed using the SF-36 (v1) quality of life tool. The patients will be assessed 3 1 year after discharge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 May 2018
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Ventricular FibrillationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Gregers Winkel
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk Foundation, Danish Heart Foundation
- Responsible party
- Sponsor-investigator, Bo Gregers Winkel, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo G Winkel, MD, Principal investigator, The Heart Center, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405229
- Sponsor's protocol ID
- 2024-518057-41-00
- Other IDs
- 2018-001683-37, H-18017757, 2018
- Acronym
- RIME-IVF
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of RIsk Factors in Out-of-hospital-cardiac-arrest Patients, and MEdical Treatment in Idiopathic Ventricular Fibrillation Patients
- ClinicalTrials.gov ID
- NCT07405229
- Acronym / sponsor ID
- RIME-IVF / 2024-518057-41-00
- Keywords
- Idiopathic Ventricular Fibrillation, IVF, cardiac arrest, beta-blocker, treatment, ventricular tachyarrhythmias, Risk markers, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Bo Gregers WinkelUniversity, hospital or other
- Collaborators
- Novo Nordisk Foundation, Danish Heart Foundation
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Feb 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.
A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Today, there is no uniform way of approaching prevention of recurrence in idiopathic ventricular fibrillation (IVF) patients, beside ICD implantation. Better reatment and risk stratification tools are needed Medical treatment in these patients has never been assessed systematically, but at least some patients with no apparent diagnosis are on betablocker treatment. It is not known if low-doselow dose betablocker treatment is beneficial in these patients.
This study investigates the effect of betablocker treatment to reduce arrhythmic burden in IVF patients.
No predictors for appropriate ICD therapy have been identified in patients with IVF. It is also explored if toxicological and/or genetic profiles, together with in depth machine learning simulation data on repolarization patterns from IVF-ECGs compared to controls, can be used as risk stratification tools.
Lastly, QOL in IVF patients and the impact of beta blocker treatment will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker | Active comparator | Drug: Beta-blocker treatment group |
| No medication | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resuscitated OHCA patients admitted to one of the participating hospitals.
- Age ≥18 years
- Suspected cardiac cause of cardiac arrest
Key exclusion criteria (6 listed)
- OHCA patients
- With Ischemic heart disease.
- Obvious non-cardiac cause of cardiac arrest
- Congenital heart disease
- Do not speak or understand Danish
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 |
|---|---|---|
| Beta-blocker treatment groupThe betablocker given to the patient will be prioritized: 1) A non-selective betablocker: Propranolol Retard 80 mg daily or Nadolol 40 mg daily OR 2) A selective betablocker: Atenolol 25 mg daily, Bisoprolol 2.5 mg daily or Metoprolol 50 mg. | Drug | Beta-blocker |
Primary outcome
First appropriate therapy by ICD or 3 years after discharge
Time frame: 3 years
Primary outcome will be either first appropriate therapy by ICD (anti tachycardia pacing or DC conversion), or aborted shock or non-sustained ventricualr fibrillation detected by the ICD, where the treating physician opts for a change in medication, or no therapy from the ICD 3 years after randomization, whichever comes first.
2 secondary outcomes
Quality of Life at 3 months
Time frame: 3 months
Quality of Life at 1 year
Time frame: 1 year
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 1 Sep 2026.
- Individual participant dataSharing planned: No. GDPR
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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.
Bo G Winkel, MD principal investigator
The Heart Center, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-blocker treatment group in people with Idiopathic Ventricular Fibrillation and Cardiac Arrest, Out-Of-Hospital, run by Bo Gregers Winkel at 2 sites 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 6 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 1 Sep 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bo G Winkel, MD, PhD (+4535459759, bo.winkel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First appropriate therapy by ICD or 3 years after discharge (time frame: 3 years). 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 1 Sep 2026.