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 julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
818
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yihong Sun
- Número de telefone: +86 15001251357
- E-mail: yihongsun72@163.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age ≥ 18 years;
- 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:
- Intolerance to heart failure pharmacotherapy;
- Severe anemia or untreated thyroid disease;
- ST-segment elevation myocardial infarction within 3 months;
- 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;
- 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;
- Existing pacemaker or planned pacemaker implantation;
- Contraindications to wearing a smartwatch (such as limb disability or known allergy to rubber/metal materials);
- Inability to access the Internet or lack of proficiency in operating smart devices.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Cuidados usuais
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Experimental: Grupo de Intervenção Assistida por Dispositivo Vestível
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Composite outcome of death or HF hospitalization
Prazo: 2 years after randomization
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2 years after randomization
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in GDMT score
Prazo: 90 days after randomization
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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.
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90 days after randomization
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NT-proBNP measures
Prazo: 2 years after randomization
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2 years after randomization
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Cardiovascular death
Prazo: 2 years after randomization
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2 years after randomization
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Stroke
Prazo: 2 years after randomization
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2 years after randomization
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Time to first readmission for heart failure (HF)
Prazo: 2 years after randomization
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2 years after randomization
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AF burden monitored by ECG straps
Prazo: 2 years after randomization
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2 years after randomization
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Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)
Prazo: 2 years after randomization
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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.
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2 years after randomization
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Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)
Prazo: 2 years after randomization
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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.
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2 years after randomization
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Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Prazo: 2 years after randomization
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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.
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2 years after randomization
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
30 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
25 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de junho de 2026
Primeira postagem (Real)
7 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KS2026104
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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