HeartLogic™ in Patients With Heart Failure.
Recruiting · NCT07544771 · Interventional (participants receive a specific treatment) · Lead sponsor: Poitiers University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.
Who can take part
Inclusion criteria
- Patients aged ≥18 years old;
- Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
- Patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with NT-proBNP blood concentration ≥450 ng/L);
- Patients with New York Heart Association Class II or III HF;
- Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
- Patients with compulsory health insurance
Exclusion criteria
- Patients not consenting and non-compliant with remote care directions.
- Patients with invasive remote HF monitoring device (such as CardioMems);
- Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
- Patients on heart transplant list, or patients with a heart transplant;
- Patients with a glomerular filtration rate \<30 ml/min/m2;
- Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration.
- Patients enable to consent.
- Patients receiving State Medical Aid (Aide Médicale d'Etat).
- Pregnant or breastfeeding women.
- Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations
Where it is running
15 locations listed.
- University hospital of Amiens - Amiens, France
- University hospital of Brest - Brest, France
- University hospital of Caen - Caen, France
- University hospital of Grenoble - Grenoble, France
- University hospital of Lille - Lille, France
- La Timone University hospital - Marseille, France
- Hopital du Confluent - Nantes, France
- University hospital of Nantes - Nantes, France
- Georges Pompidou European hospital - Paris, France
- La Pitié Salpétrière - Paris, France
- University hospital of Poitiers - Poitiers, France
- University hospital of Rouen - Rouen, France
- Pasteur clinic - Toulouse, France
- University hospital of Toulouse - Toulouse, France
- University hospital of Tours - Tours, France