Myocardial InfarctionNCT04540289
Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death
A study testing Optimal Medical Therapy (OMT) and Implantable cardioverter-defibrillator (ICD) in people with Myocardial Infarction and Sudden Cardiac Death, run by Helios Health Institute GmbH.
Trial summary
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Sudden Cardiac Death
- What is being tested?
- Optimal Medical Therapy (OMT) and Implantable cardioverter-defibrillator (ICD)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Documented history of myocardial infarction either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI).
- LVEF > 35% at transthoracic echocardiography or cardiac magnetic resonance imaging (MRI).
- Predicted personalised annual risk of SCD according to the clinical risk calculator >3%.
- Signed informed consent.
Who cannot join
- Class I or IIa indication for implantation of an ICD for secondary prevention of sudden cardiac death and ventricular tachycardia (according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death, see Appendix V).
- Ventricular tachycardia induced in an electrophysiologic study.
- Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
- Conclusive clinical indication for CRT (class I or IIa indication according to the 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)
- Carrying any implanted cardiac pacemaker, defibrillator or CRT device.
- Violation of instruction for use (IFU) of the selected ICD device by at least one of the random group treatments.
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- Hospitalised with unstable heart failure with NYHA class IV within 1 month prior to enrolment.
- Acute coronary syndrome or cardiac revascularization therapy by coronary angioplasty or coronary artery bypass grafting within 3 months prior to enrolment.
- Cardiac valve surgery or percutaneous cardiac valvular intervention such as transcatheter aortic valve replacement or transcatheter mitral valve repair performed within 3 months prior to enrolment.
- On the waiting list for heart transplantation.
- Any known disease that limits life expectancy to less than 1 year.
- Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in sub-studies connected to this trial is permitted).
- Previous participation in PROFID-Preserved.
- Drug abuse or clinically manifest alcohol abuse.
About this study
Official title: Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death (PROFID-Preserved)
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.
Read the detailed description
Sudden cardiac death (SCD) is a major public health problem, causing ~50% of cardiac fatalities and accounting for ~20% of all deaths in Europe. Identification of patients that are at risk for SCD and would benefit from ICD implantation is challenging. A predictor for increased risk of SCD after MI is a severely impaired heart function as expressed by a reduced left ventricular ejection fraction (LVEF). Based on this and on historical landmark trials, which found improved survival in patients with severely reduced LVEF who received an ICD, current clinical guidelines recommend prophylactic ICD implantation in post-MI patients with a LVEF ≤35% to improve overall survival by prevention of SCD. The current use of LVEF as sole patient stratification tool to guide treatment decisions for ICD implantation in patients with prior coronary event, as is currently recommended by clinical guidelines and performed in clinical practice, has significant limitations and results in substantial over- and undertreatment of patients. In particular, there is conclusive evidence that the majority of SCD cases occur in patients with only moderately reduced or preserved LVEF. Thus, with current guidelines most of patients that will develop SCD are not protected by means of ICD implantation.
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implanta-tion of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.
PROFID-Preserved is a non-commercial, investigator-driven, prospective, parallel-group, randomised, open-label, blinded outcome assessment (PROBE), multi-centre, superiority trial without dedicated investigational medical device (Proof of Strategy Trial) with two groups with 1:1 randomi-sation. It will be conducted in about 12 European countries with more than 150 clinical sites participating.
This study is an event driven trial and the number of randomised patients is estimated to be 1,440, required to collect 297 first primary outcome events within 30 months of mean follow-up.
Total study duration:
Enrolment of 30 months. All patients will be followed until 297 valid primary endpoints are reached (event-driven trial) which is expected about 15 months after last patient in. Total study duration of 47 months is expected which might be adapted based on a blinded interim analysis of the overall occurrence of the primary endpoint.
Individual study duration:
Expected median follow-up time will be about 30 months per patient with a minimum follow-up time of 15 months and a maximum follow-up time of presumably 45 months.
- Conditions
- Myocardial Infarction, Sudden Cardiac Death
- Being tested
- Optimal Medical Therapy (OMT), Implantable cardioverter-defibrillator (ICD)
- Keywords
- Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Implantable Cardioverter Defibrillator, PROFID, Personalized Medicine
- Medical subject headings
- Myocardial Infarction, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Medical Therapy (OMT)Drug
Patients will be treated according to Optimal Medical Therapy defined by the following guidelines:
- 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes
- 2016 ESC guidelines for the management of acute and chronic heart failure
Implantable cardioverter-defibrillator (ICD)Device
An ICD consists of an electronic medical device and electrode leads. The surgery can be performed in local anaesthesia, but a short general anaesthesia is required if the ICD has to be tested giving the patient an electric shock. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing).
The subcutaneous defibrillator is an established and valid alternative to the conventional ICD for the preven-tion of SCD. According to current guidelines, the subcutaneous defibrillator should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy for bradycardia support, cardiac resynchronisation or antitachycardia pacing is not needed.
| Study group | Role | What they receive |
|---|---|---|
| Optimal Medical Therapy without ICD device therapy | Active comparator | Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device Receives: Drug: Optimal Medical Therapy (OMT) |
| Optimal Medical Therapy with ICD device therapy | Experimental | Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device Receives: Drug: Optimal Medical Therapy (OMT); Device: Implantable cardioverter-defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to the occurrence of all-cause death
Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Secondary outcomes (5)
Time from randomisation to death from cardivascular causes
Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Time from randomisation to sudden cardiac death
Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Time from randomisation to first hospital readmissions for cardiovascular causes after randomisation
Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Average length of stay in hospital during the study period
Measured: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Quality of life (EQ-5D-5L) trajectories over time
Measured: At baseline and 6-month intervals thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Feb 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: trial is not feasible (very low event rates, no available risk predictor with acceptable predictive performance for discrimination of high-risk patients)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Hindricks, MD, Principal investigator, Department of Electrophysiology, Leipzig Heart Center at University of LeipzigNikolaos Dagres, MD, Principal investigator, Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540289
- Sponsor's protocol ID
- LHI-2020-01
- Other IDs
- 847999
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death (PROFID-Preserved)
- ClinicalTrials.gov ID
- NCT04540289
- Acronym / sponsor ID
- LHI-2020-01
- Conditions
- Myocardial Infarction, Sudden Cardiac Death
- Keywords
- Myocardial Infarction, Heart Failure, Sudden Cardiac Death, Implantable Cardioverter Defibrillator, PROFID, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: trial is not feasible (very low event rates, no available risk predictor with acceptable predictive performance for discrimination of high-risk patients)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 7 Sep 2020 (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 objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.
Detailed description
Sudden cardiac death (SCD) is a major public health problem, causing ~50% of cardiac fatalities and accounting for ~20% of all deaths in Europe. Identification of patients that are at risk for SCD and would benefit from ICD implantation is challenging. A predictor for increased risk of SCD after MI is a severely impaired heart function as expressed by a reduced left ventricular ejection fraction (LVEF). Based on this and on historical landmark trials, which found improved survival in patients with severely reduced LVEF who received an ICD, current clinical guidelines recommend prophylactic ICD implantation in post-MI patients with a LVEF ≤35% to improve overall survival by prevention of SCD. The current use of LVEF as sole patient stratification tool to guide treatment decisions for ICD implantation in patients with prior coronary event, as is currently recommended by clinical guidelines and performed in clinical practice, has significant limitations and results in substantial over- and undertreatment of patients. In particular, there is conclusive evidence that the majority of SCD cases occur in patients with only moderately reduced or preserved LVEF. Thus, with current guidelines most of patients that will develop SCD are not protected by means of ICD implantation.
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implanta-tion of an ICD (index group) is superior to optimal medical therapy (control group) with respect to all-cause mortality.
PROFID-Preserved is a non-commercial, investigator-driven, prospective, parallel-group, randomised, open-label, blinded outcome assessment (PROBE), multi-centre, superiority trial without dedicated investigational medical device (Proof of Strategy Trial) with two groups with 1:1 randomi-sation. It will be conducted in about 12 European countries with more than 150 clinical sites participating.
This study is an event driven trial and the number of randomised patients is estimated to be 1,440, required to collect 297 first primary outcome events within 30 months of mean follow-up.
Total study duration:
Enrolment of 30 months. All patients will be followed until 297 valid primary endpoints are reached (event-driven trial) which is expected about 15 months after last patient in. Total study duration of 47 months is expected which might be adapted based on a blinded interim analysis of the overall occurrence of the primary endpoint.
Individual study duration:
Expected median follow-up time will be about 30 months per patient with a minimum follow-up time of 15 months and a maximum follow-up time of presumably 45 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal Medical Therapy without ICD device therapy | Active comparator | Drug: Optimal Medical Therapy (OMT)Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device |
| Optimal Medical Therapy with ICD device therapy | Experimental | Drug: Optimal Medical Therapy (OMT), Device: Implantable cardioverter-defibrillator (ICD)Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Documented history of myocardial infarction either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI).
- LVEF > 35% at transthoracic echocardiography or cardiac magnetic resonance imaging (MRI).
- Predicted personalised annual risk of SCD according to the clinical risk calculator >3%.
- Signed informed consent.
Key exclusion criteria (14 listed)
- Class I or IIa indication for implantation of an ICD for secondary prevention of sudden cardiac death and ventricular tachycardia (according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death, see Appendix V).
- Ventricular tachycardia induced in an electrophysiologic study.
- Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
- Conclusive clinical indication for CRT (class I or IIa indication according to the 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)
- Carrying any implanted cardiac pacemaker, defibrillator or CRT device.
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 |
|---|---|---|
| Optimal Medical Therapy (OMT)Patients will be treated according to Optimal Medical Therapy defined by the following guidelines: 1. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes 2. 2016 ESC guidelines for the management of acute and chronic heart failure | Drug | Optimal Medical Therapy with ICD device therapy, Optimal Medical Therapy without ICD device therapy |
| Implantable cardioverter-defibrillator (ICD)An ICD consists of an electronic medical device and electrode leads. The surgery can be performed in local anaesthesia, but a short general anaesthesia is required if the ICD has to be tested giving the patient an electric shock. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing). The subcutaneous defibrillator is an established and valid alternative to the conventional ICD for the preven-tion of SCD. According to current guidelines, the subcutaneous defibrillator should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy for bradycardia support, cardiac resynchronisation or antitachycardia pacing is not needed. | Device | Optimal Medical Therapy with ICD device therapy |
Primary outcome
Time from randomisation to the occurrence of all-cause death
Time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)
5 secondary outcomes
Time from randomisation to death from cardivascular causes
Time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Time from randomisation to sudden cardiac death
Time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Time from randomisation to first hospital readmissions for cardiovascular causes after randomisation
Time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Average length of stay in hospital during the study period
Time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)
Quality of life (EQ-5D-5L) trajectories over time
Time frame: At baseline and 6-month intervals thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Gerhard Hindricks, MD principal investigator
Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
Nikolaos Dagres, MD principal investigator
Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Medical Therapy (OMT) and Implantable cardioverter-defibrillator (ICD) in people with Myocardial Infarction and Sudden Cardiac Death, run by Helios Health Institute GmbH.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Time from randomisation to the occurrence of all-cause death (time frame: Randomization to end of study (event-driven, expected about 15 months after last patient in)). 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 8 Mar 2023.