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Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)

7 de julio de 2026 actualizado por: Yihong Sun, Beijing Anzhen Hospital

A Researcher-initiated, Prospective, Open-label, Randomized Controlled Trial With a Parallel Design to Investigate the Prognostic Impact of Wearable Device-assisted Remote Management in Patients With Acute Heart Failure Complicated by Atrial Fibrillation

With the advancement of wearable technology, continuous non-invasive monitoring of vital signs, arrhythmia burden, and physical status has become increasingly feasible. Devices such as smartwatches and electrocardiogram (ECG) straps can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such real-time data, the complex interaction between atrial fibrillation (AF) and heart failure (HF) necessitates highly personalized management. However, there remains a lack of high-quality clinical evidence on how to effectively integrate wearable device data into these personalized strategies for specific patient populations. Moreover, the prognostic impact of wearable device-assisted remote management has not been comprehensively evaluated. Therefore, robust clinical studies are needed to further evaluate whether wearable device-assisted remote monitoring can improve the long-term prognosis of this population after discharge from the cardiac care unit (CCU).

In this study (WARM-HF Stage 2), the investigators will conduct a prospective, multicenter, randomized controlled trial to determine whether wearable devices can reduce the composite endpoint of readmission or death in patients with HF.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

818

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yihong Sun
  • Número de teléfono: +86 15001251357
  • Correo electrónico: yihongsun72@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Subjects diagnosed with acute decompensated heart failure (ADHF) :

1)Heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40%; 2)New York Heart Association (NYHA) functional class II-IV; 3)NT-proBNP > 2500 pg/mL or BNP > 600 pg/mL 3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting > 30 seconds on electrocardiogram [ECG] within the past 12 months)

Exclusion Criteria:

  1. Intolerance to heart failure pharmacotherapy;
  2. Severe anemia or untreated thyroid disease;
  3. ST-segment elevation myocardial infarction within 3 months;
  4. Known complex congenital heart disease; infiltrative cardiomyopathy (such as cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy; or uncorrected primary valvular heart disease requiring surgical interventions;
  5. Prior major cardiac surgery or mechanical circulatory support, or planned within 6 months, including coronary artery bypass grafting, cardiac valve repair or replacement, ventricular assist device or mechanical circulatory support device implantation, and heart transplantation;
  6. Existing pacemaker or planned pacemaker implantation;
  7. Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber/metal materials);
  8. Inability to access the Internet or lack of proficiency in operating smart devices.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Sin intervención: Cuidado usual
Experimental: Grupo de Intervención Asistida por Dispositivo Vestible
Participants in the intervention group will be managed per current guidelines for heart failure (HF) and/or atrial fibrillation (AF). The intervention group uses real-time data for automatic triage, categorized into three subgroups: Normal subgroup: Upward titration of guideline-directed medical therapy (GDMT). Abnormal subgroup: Upward/downward GDMT titration, or volume/congestion management (dyspnea/edema) - diuretics titrated to 100% target dose or other diuretics added. Grade E alert subgroup: Emergency department (ED) or outpatient clinic visit. Efforts to maintain sinus rhythm are recommended; rate control strategies are at the discretion of physicians. Anticoagulation will be initiated, if not already started, and maintained throughout the study according to current guidelines.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Composite outcome of death or HF hospitalization
Periodo de tiempo: 2 years after randomization
2 years after randomization

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in GDMT score
Periodo de tiempo: 90 days after randomization
The GDMT(guideline-directed medical therapy) score is a scoring system according to the combination of GDMT drugs administration and their dosages. Renin-angiotensin system (RAS) inhibitors were scored 0 if not initiated, 1 if <50% of target dose, and 2 if 50-100% of target dose; ARNIs were scored 3 regardless of dose; BBs were scored 0 if not initiated, 1 if <50% of target dose, and 2 if 50-100% of target dose; and MRAs and SGLT2 inhibitors were scored 0 if not initiated and 2 if initiated regardless of dose. MRAs and SGLT2 inhibitors were scored 0 if not initiated and 2 if initiated regardless of dose, resulting in a total score of 0-9. The higher score indicated better implementation of GDMT therapy.
90 days after randomization
NT-proBNP measures
Periodo de tiempo: 2 years after randomization
2 years after randomization
Cardiovascular death
Periodo de tiempo: 2 years after randomization
2 years after randomization
Stroke
Periodo de tiempo: 2 years after randomization
2 years after randomization
Time to first readmission for heart failure (HF)
Periodo de tiempo: 2 years after randomization
2 years after randomization
AF burden monitored by ECG straps
Periodo de tiempo: 2 years after randomization
2 years after randomization
Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)
Periodo de tiempo: 2 years after randomization
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life for patients with congestive heart failure. The KCCQ-OS scores range from 0 to 100, with lower scores denoting poorer quality of life.
2 years after randomization
Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)
Periodo de tiempo: 2 years after randomization
The Minnesota Failure Quality of Life Scale (MLHFO) was especially developed for patients with HF to measure their overall health-related quality of life. It contains 21 questions about the impact of HF on patient's daily life. A total score between 0 and 105 can be achieved, with a higher score indicating poorer quality of life.
2 years after randomization
Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Periodo de tiempo: 2 years after randomization
The descriptive system of the EuroQol five-dimensional questionnaire(EQ-5D) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension is described at five levels, corresponding roughly to no, slight, moderate, severe, and extreme problems. A health profile and a single health state index value can be derived. This index value ranges between <0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). In addition, a visual analogue scale records the respondent's self-rated health status on a vertical graduated (0-100) scale.
2 years after randomization

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

30 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de junio de 2026

Publicado por primera vez (Actual)

7 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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