Remote Monitoring and Optimization of Heart Failure Therapy (REMODEL-HF)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
Sauvegarde des contacts de l'étude
- Nom: Lars Weber, PhD
- Numéro de téléphone: +49 (0) 151 611 404 98
- E-mail: lweber@zoll.com
Lieux d'étude
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Giessen, Allemagne, 35390
- Justus-Liebig University Giessen
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Contact:
- Nour Katnahji, PhD
- Numéro de téléphone: +49 (0) 170 8862 141
- E-mail: nour.katnahji@zoll.com
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Chercheur principal:
- Brigit Assmus, MD
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Madrid, Espagne
- Hospital Universitario 12 de Octubre
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Contact:
- Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
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Grand Est
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Nancy, Grand Est, France, 54000
- CHU Nancy
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Contact:
- Sarah Klepp, PhD
- Numéro de téléphone: +49 (0) 151 40373 869
- E-mail: sarah.klepp@zoll.com
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Chercheur principal:
- Nicolas Girerd, Professor
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Roma, Italie
- Policlinico Casilino
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Contact:
- Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
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Utrecht, Pays-Bas
- UMC Utrecht
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Warsaw, Pologne
- PIM MSWiA Hospital
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Contact:
- Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
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Chercheur principal:
- Agnieszka Pawlak, Professor
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Southampton, Royaume-Uni
- Southampton University Hospital NHS Foundation Trust
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Contact:
- Olta Ibruli, PhD
- Numéro de téléphone: +49 (0) 171 152 32 94
- E-mail: olta.ibruli@zoll.com
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Chercheur principal:
- Peter COWBURN, MD
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Zurich, Suisse
- University Zurich
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Contact:
- Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
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Uppsala, Suède
- Uppsala University Hospital
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Contact:
- Manon Lemaire, Master
- Numéro de téléphone: +33 (0)6 33 57 18 52
- E-mail: mlemaire@zoll.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Control Group
Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device.
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Comparateur actif: 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.
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Hierarchical Composite Outcome (Win Ratio)
Délai: 90 days
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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.
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90 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)
Délai: 90 days
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Percentage of participants reaching target doses of guideline-directed medical therapy for heart failure during the first 90 days after randomization.
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90 days
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Quality of Life Assessed by KCCQ-12
Délai: Baseline, 90 days,180 days and 365 days
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Change in health-related quality of life measured using validated questionnaire : the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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Baseline, 90 days,180 days and 365 days
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Time to First Clinical Event Composite
Délai: Up to 365 days
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Time to First Occurrence of Cardiovascular Death, Heart Failure Hospitalization, or Unplanned Visit Requiring Intravenous Diuretic Treatment
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Up to 365 days
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Quality of Life Assessed by EQ-5D-5L
Délai: Baseline, 90 days,180 days and 365 days
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Change in health-related quality of life measured using validated questionnaire : the EQ-5D-5L
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Baseline, 90 days,180 days and 365 days
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Hierarchical Composite Outcome (Win Ratio at 1 Year)
Délai: 365 days
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Hierarchical composite outcome using the same win ratio methodology as the primary endpoint, evaluated at 1 year.
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365 days
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Cardiovascular Death
Délai: 90 days and 365 days
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Occurrence of death due to cardiovascular causes.
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90 days and 365 days
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Heart Failure Hospitalization
Délai: 90 days and 365 days
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Occurrence of hospitalization due to heart failure.
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90 days and 365 days
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Unplanned Visit Requiring Intravenous Diuretic Treatment
Délai: 90 days and 365 days
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Occurrence of an unplanned visit requiring intravenous diuretic treatment.
Scheduled or planned intravenous diuretic treatments are not considered events.
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90 days and 365 days
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NT-proBNP Response
Délai: Baseline to 90 days
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Change in NT-proBNP concentration from baseline.
Response defined as ≥30% decrease from baseline.
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Baseline to 90 days
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
- Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.
- Scholte NTB, Gurgoze MT, Aydin D, Theuns DAMJ, Manintveld OC, Ronner E, Boersma E, de Boer RA, van der Boon RMA, Brugts JJ. Telemonitoring for heart failure: a meta-analysis. Eur Heart J. 2023 Aug 14;44(31):2911-2926. doi: 10.1093/eurheartj/ehad280.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 90d0278
- 101253160 (Autre subvention/numéro de financement: Granting Authority :Innovative Health Initiative Joint Undertaking (IHI JU) and Funding Program: Horizon Europe)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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