NCT04619888Completed
HeartLogic France Study: Heart Failure Patients Managed with the HeartLogic Algorithm
Follow-up of Heart Failure Patients with an Implantable Cardiac Defibrillator Enabled with the HeartLogic Algorithm - HeartLogic France Study
Source: ClinicalTrials.gov · Last updated 19 Nov 2024
Brief summary (registry, in English)
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France. The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm. Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L). If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 310 (actual)
- First submitted
- 2 Nov 2020
- Start date
- 10 Mar 2021
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Heart failure
- NCT number
- NCT04619888
What you commit to
- Study type: Observational
- Participants enrolled: 310
- From 10 Mar 2021 to the primary completion date, 30 Jul 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant presence of a heart failure device other than cardiac resynchronisation such as a left ventricular assist device or a device for modulating cardiac contractility.
Other illness
- Heart transplant project, or heart transplant patient
- Refusal to take medication for heart failure
- Patient with a mechanical heart valve
Other
- Glomerular filtration rate \<30 ml/mn/m2 or dialysis,
- Life expectancy ≤ 6 months
- Remote monitoring of HeartLogic is not possible.
Who the study is looking for
- Patient implanted with a cardiac defibrillator, with or without resynchronization, enabled with the HeartLogic index (RESONATE family, Boston Scientific)
- History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| University hospital of Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hospital of Lorient Coordinator of this site? Confirm its status | Lorient | France | Unknown status |
| University Hospital of Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Clinique du Confluent Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital Européen G Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital La Salpétrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| University Hospital of Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| University Hospital of Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
Related publications
- Impact and safety of remote monitoring of heart failure patients managed with the HeartLogic algorithm: the HeartLogic France Cohort Study.Eur Heart J Digit Health · 2026 · PMID 41624570
This page is information, not medical advice. Discuss any trial with your doctor.