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Remote Monitoring and Optimization of Heart Failure Therapy (REMODEL-HF)

1 giugno 2026 aggiornato da: Zoll Medical Corporation

Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission.

This study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure.

Participants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure.

Participants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life.

The goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The REMODEL-HF study is a prospective, multi-center, randomized, open-label clinical investigation designed to evaluate whether the use of HFMS in addition to usual care improves clinical outcomes in patients recently hospitalized for acute heart failure.

Approximately 800 participants will be enrolled and randomized in a 1:1 ratio to either: standard of care alone (control group), or standard of care plus HFMS-guided management (intervention group).

The primary objective is to determine whether HFMS-guided management results in improved overall clinical outcomes compared to usual care. Outcomes of interest include major clinical events such as cardiovascular death and heart failure hospitalization, as well as earlier indicators of clinical deterioration and changes in relevant biomarkers.

Tipo di studio

Interventistico

Iscrizione (Stimato)

800

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Manon Lemaire, Master
  • Numero di telefono: +33 (0)6 33 57 18 52
  • Email: mlemaire@zoll.com

Backup dei contatti dello studio

  • Nome: Lars Weber, PhD
  • Numero di telefono: +49 (0) 151 611 404 98
  • Email: lweber@zoll.com

Luoghi di studio

  • Francia
    • Grand Est
      • Nancy, Grand Est, Francia, 54000
        • CHU Nancy
        • Contatto:
        • Investigatore principale:
          • Nicolas Girerd, Professor
  • Germania
      • Giessen, Germania, 35390
        • Justus-Liebig University Giessen
        • Contatto:
        • Investigatore principale:
          • Brigit Assmus, MD
  • Italia
      • Roma, Italia
        • Policlinico Casilino
        • Contatto:
          • Manon Lemaire, Master
          • Numero di telefono: +33 (0)6 33 57 18 52
          • Email: mlemaire@zoll.com
  • Olanda
      • Utrecht, Olanda
        • UMC Utrecht
  • Polonia
      • Warsaw, Polonia
        • PIM MSWiA Hospital
        • Contatto:
          • Manon Lemaire, Master
          • Numero di telefono: +33 (0)6 33 57 18 52
          • Email: mlemaire@zoll.com
        • Investigatore principale:
          • Agnieszka Pawlak, Professor
  • Regno Unito
      • Southampton, Regno Unito
        • Southampton University Hospital NHS Foundation Trust
        • Contatto:
        • Investigatore principale:
          • Peter COWBURN, MD
  • Spagna
      • Madrid, Spagna
        • Hospital Universitario 12 de Octubre
        • Contatto:
          • Manon Lemaire, Master
          • Numero di telefono: +33 (0)6 33 57 18 52
          • Email: mlemaire@zoll.com
  • Svezia
      • Uppsala, Svezia
        • Uppsala University Hospital
        • Contatto:
          • Manon Lemaire, Master
          • Numero di telefono: +33 (0)6 33 57 18 52
          • Email: mlemaire@zoll.com
  • Svizzera
      • Zurich, Svizzera
        • University Zurich
        • Contatto:
          • Manon Lemaire, Master
          • Numero di telefono: +33 (0)6 33 57 18 52
          • Email: mlemaire@zoll.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥18 years
  • Ability and willingness to provide written informed consent and comply with study procedures
  • Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
  • All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
  • All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq/L (mmol/L).

  • Biomarker criteria for persistent congestion:

    • NT-proBNP >1500 pg/mL at the time of admission, and;
    • NT-proBNP >1000 pg/mL >=3 days after initial admission measure
  • At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment.

Exclusion Criteria:

  • Age < 18 years
  • Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers.
  • Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB).
  • Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
  • Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension.
  • Cardiac surgery within 3 months prior to Screening
  • Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded.
  • Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy.
  • History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
  • Adhesive allergy/sensitivity (e.g., acrylic adhesives).
  • Compromised skin at the device application site (wound, severe dermatitis, etc.) .
  • Having a prescribed wearable cardioverter defibrillator
  • Pulmonary artery pressure implant (e.g. CardioMems)
  • Expected survival <1 year

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Group
Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device.
Comparatore attivo: Intervention Group
Participants receive standard medical care in addition to remote monitoring using the Heart Failure Management System (HFMS). Clinical teams review device data and may adjust treatment based on observed trends and alerts.
Dispositivo: Wearable Monitoring Device for Heart Failure

Participants assigned to the intervention group will use a noninvasive wearable physiological monitoring device (Heart Failure Management System, HFMS) designed to continuously collect data related to cardiopulmonary status, including heart rate, respiratory parameters, activity levels, and indicators of fluid status (Thoraic Fluid Index = TFI).

Clinical care teams perform regular reviews of device-derived data and may respond to alerts or trends suggestive of worsening heart failure.

Based on these data, the care team may adjust patient management, including modification of guideline-directed medical therapy or scheduling of follow-up assessments. The device does not deliver therapy and is used to support clinical decision-making in the outpatient management of heart failure.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hierarchical Composite Outcome (Win Ratio)
Lasso di tempo: 90 days
A hierarchical composite outcome comparing the intervention and control groups using a win ratio approach. The components are prioritized as follows: (1) cardiovascular death, (2) heart failure hospitalization, (3) Unplanned visit (emergency room or other emergency facilities) requiring intravenous diuretic treatment, and (4) change in NT-proBNP concentration. Participants are compared pairwise, with outcomes evaluated sequentially according to this hierarchy.
90 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)
Lasso di tempo: 90 days
Percentage of participants reaching target doses of guideline-directed medical therapy for heart failure during the first 90 days after randomization.
90 days
Quality of Life Assessed by KCCQ-12
Lasso di tempo: Baseline, 90 days,180 days and 365 days
Change in health-related quality of life measured using validated questionnaire : the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Baseline, 90 days,180 days and 365 days
Time to First Clinical Event Composite
Lasso di tempo: Up to 365 days
Time to First Occurrence of Cardiovascular Death, Heart Failure Hospitalization, or Unplanned Visit Requiring Intravenous Diuretic Treatment
Up to 365 days
Quality of Life Assessed by EQ-5D-5L
Lasso di tempo: Baseline, 90 days,180 days and 365 days
Change in health-related quality of life measured using validated questionnaire : the EQ-5D-5L
Baseline, 90 days,180 days and 365 days
Hierarchical Composite Outcome (Win Ratio at 1 Year)
Lasso di tempo: 365 days
Hierarchical composite outcome using the same win ratio methodology as the primary endpoint, evaluated at 1 year.
365 days
Cardiovascular Death
Lasso di tempo: 90 days and 365 days
Occurrence of death due to cardiovascular causes.
90 days and 365 days
Heart Failure Hospitalization
Lasso di tempo: 90 days and 365 days
Occurrence of hospitalization due to heart failure.
90 days and 365 days
Unplanned Visit Requiring Intravenous Diuretic Treatment
Lasso di tempo: 90 days and 365 days
Occurrence of an unplanned visit requiring intravenous diuretic treatment. Scheduled or planned intravenous diuretic treatments are not considered events.
90 days and 365 days
NT-proBNP Response
Lasso di tempo: Baseline to 90 days
Change in NT-proBNP concentration from baseline. Response defined as ≥30% decrease from baseline.
Baseline to 90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zoll Medical Corporation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 agosto 2029

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 90d0278
  • 101253160 (Altro numero di sovvenzione/finanziamento: Granting Authority :Innovative Health Initiative Joint Undertaking (IHI JU) and Funding Program: Horizon Europe)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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