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Studies

Interventional Recruiting

NCT07544771 on ClinicalTrials.gov

HeartLogic™ in Patients With Heart Failure.

Official title: HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.

  • Sponsor: Centre Hospitalier Universitaire de Poitiers
  • Enrollment: 578 (Estimated)
  • Study start: 2026-04-29 (Actual)
  • Primary completion: 2028-10-15 (Estimated)
  • Study completion: 2029-05-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Heart Failure

Intervention / Treatment

  • Other: Alert-guided remote follow-up
  • Other: Traditional follow up

Primary Outcome Measures

  • Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life. (12-month follow-up)
    The primary outcome is the proportion of patients, at 12 months, who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life, defined as a reduction of 5 points or more in the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Countries

France

Locations and Investigators

  • University hospital of Amiens, Amiens, France (Not yet recruiting)
    • Alexis Hermida
  • University hospital of Brest, Brest, France (Not yet recruiting)
    • Jacques Mansourati
  • University hospital of Caen, Caen, France (Not yet recruiting)
    • Laure Champ-Rigot
  • University hospital of Grenoble, Grenoble, France (Not yet recruiting)
    • Pascal Defaye
  • University hospital of Lille, Lille, France (Not yet recruiting)
    • Cédric Klein
  • La Timone University hospital, Marseille, France (Not yet recruiting)
    • Baptiste Maille
  • Hopital du Confluent, Nantes, France (Not yet recruiting)
    • Daniel Gras
  • University hospital of Nantes, Nantes, France (Not yet recruiting)
    • Vincent Probst
  • Georges Pompidou European hospital, Paris, France (Not yet recruiting)
    • Eloi Marijon
  • La Pitié Salpétrière, Paris, France (Not yet recruiting)
    • Caroline Himbert
  • University hospital of Poitiers, Poitiers, France (Recruiting)
    • Rodrigue Garcia
  • University hospital of Rouen, Rouen, France (Not yet recruiting)
    • Frédéric Anselme
  • Pasteur clinic, Toulouse, France (Not yet recruiting)
    • Serge Boveda
  • University hospital of Toulouse, Toulouse, France (Not yet recruiting)
    • Romain Itier
  • University hospital of Tours, Tours, France (Not yet recruiting)
    • Arnaud Bisson