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Prevention study for Heart Failure
Official title Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
ClinicalTrials.gov ID: NCT05373940
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- ≥70 years old,
- Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography...
- 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...
- Providing informed consent
You likely can't join if
- Enrolled in or planning to enroll in a conflicting treatment trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC...
- 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)
See the full eligibility criteria
- ≥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...
- 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...
- Providing informed consent
- Affiliated to a French Health Insurance system.
- Enrolled in or planning to enroll in a conflicting treatment 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Amiens, France
- Brest, France
- Créteil, France
- La Tronche, France
- Lomme, France
- Marseille, France
- Nancy, France
- Nantes, France
- Paris, France
- Poitiers, France
- Rennes, France
- Rouen, France
- Saint-Denis, France
- Strasbourg, France
- Toulouse, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Amiens, France; Brest, France; Créteil, France; La Tronche, France; Lomme, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.