Heart FailureDILEMMANCT05373940
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
A study testing ICD implantation and No ICD implantation in people with Heart Failure and Primary Prevention of Sudden Cardiac Death, run by Assistance Publique - Hôpitaux de Paris at 19 sites in France.
Trial summary
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- What is being tested?
- ICD implantation and No ICD implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 19 sitesFrance
- Study dates
- 29 Jun 2022to 31 May 2030
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥70 years old,
- Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).
- NYHA class II or III
- Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)
- Providing informed consent
- Affiliated to a French Health Insurance system.
Who cannot join
- Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)
- Prior unstable sustained ventricular arrhythmia requiring external cardioversion
- Myocardial infarction within the 40 days
- Coronary artery intervention (catheter or surgical) within 90 days
- History of syncope in the previous 6 months
- Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy)
Show all 10Show fewer
- Cognitive impairment leading to the incapacity of consent
- Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
- Patient under tutorship, curatorship, or legal safeguard
- Persons deprived of their liberty by judicial or administrative decision (prisoner)
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
Centre Hospitalier d'Aix en provence
Aix-en-Provence, 13616
Jérôme TAIEB, MD, 04 42 33 50 53, jtaieb@ch-aix.fr
- Recruiting
CHU Amiens-Picardie-Site sud
Amiens, 80054
Alexis HERMIDA-JARRY, MD, hermida.alexis@chu-amiens.fr
- Recruiting
CHU Brest - Hôpital La Cavale Blanche
Brest, 29200
Jacques MANSOURATI, Pr, 02 98 34 73 73, jacques.mansourati@chu-brest.fr
- Recruiting
HôpitalHenri Mondor
Créteil, 94000
Nicolas LELLOUCHE, MD, PhD, 0149814350, nicolas.lellouche@aphp.fr
- Recruiting
CHU Grenoble Alpes
La Tronche, 38700
Pascal DEFAYE, MD, PhD, 04 76 76 75 75, pdefaye@chu-grenoble.fr
- Recruiting
Groupement d'Hôpitaux de l'Institut Catholique de Lille
Lomme, 59462
Aymeric MENET, MD, 03 20 22 50 57, menet.aymeric@ghicl.net
- Recruiting
Hôpital de La Timone
Marseille, 13385
Jean Claude DEHARO, MD, PhD, 04 91 38 65 90, jean-claude.deharo@ap-hm.fr
- Recruiting
Hôpital de Brabois
Nancy, 54710
Mathieu ECHIVARD, MD, m.echivard@chru-nancy.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Vincent PROBST, MD, PhD, 02 40 16 50 08, vincent.probst@chu-nantes.fr
- Recruiting
Hôpital européen Georges Pompidou
Paris, , 75015
Eloi MARIJON, MD, PhD, 01 56 09 36 92, eloi.marijon@aphp.fr
- Recruiting
Hôpital Pitié-Salpétrière
Paris, 75013
Estelle GANDJBAKHCH, MD, PhD, 01 42 16 30 55, estelle.gandjbakhch@aphp.fr
- Recruiting
Hôpital Bichat - Claude Bernard
Paris, 75014
Fabrice EXTRAMIANA, MD, PhD, 0140258236, fabrice.extramiana@aphp.fr
- Recruiting
CHU Poitiers
Poitiers, 86021
Rodrigue Garcia, MD, PhD, rodrigue.garcia@chu-poitiers.fr
- Recruiting
Hôpital Pontchaillou
Rennes, 35033
Christophe LECLERCQ, MD, 0299282525, christophe.leclercq@chu-rennes.fr
- Recruiting
CHU de Rouen
Rouen, 76000
Frédéric ANSELME, MD, PhD, 02 32 88 81 11, frederic.anselme@chu-rouen.fr
- Recruiting
Centre Cardiologique du Nord
Saint-Denis, 93207
Olivier PIOT, MD, 01 49 33 41 82, o.piot@ccn.fr
- Recruiting
CHU Strasbourg
Strasbourg, 67200
Laurence JESEL-MOREL, MD, PhD, 03 69 55 09 48, laurence.jesel-morel@chru-strasbourg.fr
- Recruiting
Clinique Pasteur
Toulouse, 31076
Serge BOVEDA, MD, PhD, 05 62 21 16 45, sboveda@clinique-pasteur.com
- Recruiting
Hôpital Trousseau
Tours, 37170
Laurent FAUCHIER, MD, 02 47 47 87 83, laurent.fauchier@univ-tours.fr
About this study
Official title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Read the detailed description
Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.
Main objective The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.
- Conditions
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Being tested
- ICD implantation, No ICD implantation
- Keywords
- Heart Failure, Prevention strategy of Sudden Cardiac Death, Implantable cardioverter defibrillator, Heart Failure Optimal Therapy, Mortality
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantationDevice
This group will undergo an ICD implantation (type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization.
Patients of the "HFOT+ICD" group will be scheduled for ICD implantation.
No ICD implantationDevice
Patients of the "HFOT alone" group will not undergo ICD implantation (except if they develop sustained ventricular arrhythmias and fulfil for secondary prevention ICD implantation), and continue with medical therapy optimization only.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure optimal therapy alone (HFOT) | Experimental | Heart failure Optimal therapy without implantable cardioverter defibrillator. This group will not undergo an ICD implantation. They will be treated according to the HFOT recommended in the latest guidelines. Receives: Device: No ICD implantation |
| Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD) | Active comparator | Optimal medical therapy + implantable cardioverter defibrillator (HFOT+ICD). This group will undergo an ICD implantation (standard of care), any brand, CE marked, implantable (lifelong), available and reimbursed in the French market (the type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization. Receives: Device: ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The primary endpoint will be the overall survival at 48 months after randomization to "HFOT alone" group or "HFOT+ICD" group.
There is an annual follow-up with precise date of the fatal event and specific cause of death adjudicated by the blinded event committee.
Measured: 48 months after randomization
Secondary outcomes (9)
Cardiovascular mortality
Rate of cardiovascular mortality assessed by a blinded endpoint committee.
Measured: 48 months after randomization
Sudden cardiac death and death from ventricular arrhythmias
Rate of sudden cardiac death and rate of death from ventricular arrhythmias assessed by a blinded endpoint committee.
Measured: 48 months after randomization
Unplanned hospitalization due to cardiovascular causes
Number of unplanned hospitalization due to cardiovascular causes
Measured: 48 months after randomization
ICD related complications including inappropriate therapies
Number of ICD related therapies (antitachycardia pacing and shocks), hematoma, infection related to the device, lead dislodgement requiring intervention, pneumothorax and tamponade.
Measured: 48 months after randomization
Global quality of life score with 36-Item Short Form Survey (SF36)
Global quality of life score with SF36 (Short form 36 health survey) : the norm data is 0-100, the health related quality of life is increased as the scores are increased.
Measured: baseline, 6, 12, 24, 36 and 48 months
Health-related quality of life score Euroqol EQ-5D questionnaire
Health-related quality of life measured by using the European Quality Of Life (EQ-5D) auto-questionnaire. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The visual analogue scale (VAS) records the patient's self-rated health on a vertical axis from 0 (worst health) to 100 (best health)
Measured: baseline, 6, 12, 24, 36 and 48 months
Patient's global self-assessment of heart failure-related quality of life score
The Minnesota Living with Heart Failure will be used to measure the subjects perception of how their heart failure affect their life. Norm data is 0-105 (21 items ; score 0-5), quality of life increases as scores decrease.
Measured: baseline, 6, 12, 24, 36 and 48 months
The Incremental cost-utility ratio. (ICUR)
The ICUR is calculated by dividing the difference between the average costs of both groups by the difference in mean QALYs gained in both groups. The QALYs will be constructed with the EuroQoL-5D (EQ-5D) questionnaire and value sets.
Measured: 48 months
The incremental cost-effectiveness ratio (ICER)
The ICER will estimate the cost per additional survivor and is calculated by dividing the difference between the average costs of both groups by the difference in effectiveness (survival) between both groups.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start29 Jun 2022
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Model description
- This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Eloi MARIJON, MD, PhD, Principal investigator, AP-HP, Hôpital européen Georges Pompidou, ParisRodrigue GARCIA, MD, PhD, Study director, CHU Poitiers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373940
- Sponsor's protocol ID
- APHP200035
- Other IDs
- 2021-A01959-32
- Acronym
- DILEMMA
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05373940
- Acronym / sponsor ID
- DILEMMA / APHP200035
- Conditions
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Keywords
- Heart Failure, Prevention strategy of Sudden Cardiac Death, Implantable cardioverter defibrillator, Heart Failure Optimal Therapy, Mortality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 13 May 2022 (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 primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Detailed description
Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.
Main objective The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Heart failure optimal therapy alone (HFOT) | Experimental | Device: No ICD implantationHeart failure Optimal therapy without implantable cardioverter defibrillator. This group will not undergo an ICD implantation. They will be treated according to the HFOT recommended in the latest guidelines. |
| Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD) | Active comparator | Device: ICD implantationOptimal medical therapy + implantable cardioverter defibrillator (HFOT+ICD). This group will undergo an ICD implantation (standard of care), any brand, CE marked, implantable (lifelong), available and reimbursed in the French market (the type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- ≥70 years old,
- Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).
- NYHA class II or III
- Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)
- Providing informed consent
Key exclusion criteria (10 listed)
- Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)
- Prior unstable sustained ventricular arrhythmia requiring external cardioversion
- Myocardial infarction within the 40 days
- Coronary artery intervention (catheter or surgical) within 90 days
- History of syncope in the previous 6 months
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 |
|---|---|---|
| ICD implantationThis group will undergo an ICD implantation (type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization. Patients of the "HFOT+ICD" group will be scheduled for ICD implantation. | Device | Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD) |
| No ICD implantationPatients of the "HFOT alone" group will not undergo ICD implantation (except if they develop sustained ventricular arrhythmias and fulfil for secondary prevention ICD implantation), and continue with medical therapy optimization only. | Device | Heart failure optimal therapy alone (HFOT) |
Primary outcome
Overall survival
Time frame: 48 months after randomization
The primary endpoint will be the overall survival at 48 months after randomization to "HFOT alone" group or "HFOT+ICD" group. There is an annual follow-up with precise date of the fatal event and specific cause of death adjudicated by the blinded event committee.
9 secondary outcomes
Cardiovascular mortality
Time frame: 48 months after randomization
Sudden cardiac death and death from ventricular arrhythmias
Time frame: 48 months after randomization
Unplanned hospitalization due to cardiovascular causes
Time frame: 48 months after randomization
ICD related complications including inappropriate therapies
Time frame: 48 months after randomization
Global quality of life score with 36-Item Short Form Survey (SF36)
Time frame: baseline, 6, 12, 24, 36 and 48 months
Health-related quality of life score Euroqol EQ-5D questionnaire
Time frame: baseline, 6, 12, 24, 36 and 48 months
Patient's global self-assessment of heart failure-related quality of life score
Time frame: baseline, 6, 12, 24, 36 and 48 months
The Incremental cost-utility ratio. (ICUR)
Time frame: 48 months
The incremental cost-effectiveness ratio (ICER)
Time frame: 48 months
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 24 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Eloi MARIJON, MD, PhD principal investigator
AP-HP, Hôpital européen Georges Pompidou, Paris
Rodrigue GARCIA, MD, PhD study director
CHU Poitiers, France
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD implantation and No ICD implantation in people with Heart Failure and Primary Prevention of Sudden Cardiac Death, run by Assistance Publique - Hôpitaux de Paris at 19 sites in France.
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 6 inclusion and 10 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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.
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 Alexandra BRUNEAU, Mrs (+33144841712, alexandra.bruneau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 48 months after randomization). 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 24 Mar 2026.