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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
Copia de seguridad de contactos de estudio
- Nombre: Lars Weber, PhD
- Número de teléfono: +49 (0) 151 611 404 98
- Correo electrónico: lweber@zoll.com
Ubicaciones de estudio
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Giessen, Alemania, 35390
- Justus-Liebig University Giessen
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Contacto:
- Nour Katnahji, PhD
- Número de teléfono: +49 (0) 170 8862 141
- Correo electrónico: nour.katnahji@zoll.com
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Investigador principal:
- Brigit Assmus, MD
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Madrid, España
- Hospital Universitario 12 de Octubre
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Contacto:
- Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
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Grand Est
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Nancy, Grand Est, Francia, 54000
- CHU Nancy
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Contacto:
- Sarah Klepp, PhD
- Número de teléfono: +49 (0) 151 40373 869
- Correo electrónico: sarah.klepp@zoll.com
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Investigador principal:
- Nicolas Girerd, Professor
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Roma, Italia
- Policlinico Casilino
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Contacto:
- Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
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Utrecht, Países Bajos
- UMC Utrecht
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Warsaw, Polonia
- PIM MSWiA Hospital
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Contacto:
- Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
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Investigador principal:
- Agnieszka Pawlak, Professor
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Southampton, Reino Unido
- Southampton University Hospital NHS Foundation Trust
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Contacto:
- Olta Ibruli, PhD
- Número de teléfono: +49 (0) 171 152 32 94
- Correo electrónico: olta.ibruli@zoll.com
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Investigador principal:
- Peter COWBURN, MD
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Uppsala, Suecia
- Uppsala University Hospital
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Contacto:
- Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
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Zurich, Suiza
- University Zurich
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Contacto:
- Manon Lemaire, Master
- Número de teléfono: +33 (0)6 33 57 18 52
- Correo electrónico: mlemaire@zoll.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hierarchical Composite Outcome (Win Ratio)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of Participants Achieving Target Doses of Guideline-Directed Medical Therapy (GDMT)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 90d0278
- 101253160 (Otro número de subvención/financiamiento: Granting Authority :Innovative Health Initiative Joint Undertaking (IHI JU) and Funding Program: Horizon Europe)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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