Novo dispositivo vestível para gerenciamento de insuficiência cardíaca
Pesquisa clínica translacional de um novo dispositivo vestível baseado em tecnologia de detecção patenteada no tratamento não invasivo da insuficiência cardíaca
Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Di Sun, Dr.
- Número de telefone: 010-84206809
- E-mail: sundi0929@163.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of HF ≥ 3 months
- Diagnosis of NYHA Class III HF
- Subjects with age ≥ 18 years
- At least 1 HF hospitalization within 12 months prior to enrollment
- Subjects with elevated ambulatory levels of BNP/NT-proBNP
Exclusion Criteria:
- Subjects unable to cooperate to complete the trial.
- Subjects with severe arrhythmia.
- Subjects with cardiac shock.
- Subjects with acute myocardial infarction.
- Subjects with local skin infections and injuries in the jugular vein area
- Subjects with active uncontrolled infections
- Subjects with eGFR < 25 mL/min/1.73m2
- Pregnant women, or women likely to undergo pregnancy
- Subjects with life expectancy less than 6 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Novel wearable device strategy group
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps. |
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge. |
|
Sem intervenção: Control group
Patients receive a standard of care for heart failure without a wearable device. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Rate of Hospital Readmissions for Heart Failure
Prazo: Up to 6 months
|
Total hospitalizations for heart failure will be monitored via follow-up. |
Up to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concordance of the Jugular Vein Pressure with the RHC Measurement
Prazo: Up to 6 months
|
Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization. |
Up to 6 months
|
|
Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
Prazo: Up to 6 months
|
Change from baseline to 6 months in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain Natriuretic Peptide(BNP). NT-proBNP/BNP level will be measured using commercial kits system during the follow-up period. Change from baseline was defined as the value of NT-proBNP/BNP at 6 months minus the baseline value. Baseline value was defined as the mean of all available measurements from the screening visit. |
Up to 6 months
|
|
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
Prazo: Up to 6 months
|
Change from baseline to 6 months in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. |
Up to 6 months
|
|
Compliance Percentage of Patients
Prazo: Up to 6 months
|
Patient adherence to daily measurement and transmission of sensor readings will be recorded. |
Up to 6 months
|
|
Change in Quality of Life
Prazo: Up to 6 months
|
Quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) answered by the patients directly on a patient application.KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
Up to 6 months
|
|
Change in New York Heart Association (NYHA) functional class.
Prazo: Up to 6 months
|
NYHA class will be evaluated according to the patients' clinical characteristics during the follow-up.NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity; Class I being best and Class IV being the worst functional class. Class I has no limitation to physical activity, Class II has slight limitation to physical activity, Class III has marked limitation of physical activity, and Class IV is unable to carry out any physical activity without severe discomfort. |
Up to 6 months
|
|
Freedom From a Device/System-related Complication
Prazo: Up to 6 months
|
Device/System-related Complications refer to adverse events such as device failure and allergy. |
Up to 6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Subjects Included the Endpoint of Cardiovascular Mortality
Prazo: Up to 6 months
|
Rate of cardiovascular mortality will be monitored via follow-up. |
Up to 6 months
|
|
Subjects Included the Endpoint of all-cause Mortality
Prazo: Up to 6 months
|
Rate of all-cause mortality will be monitored via follow-up. |
Up to 6 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2022-NHLHCRF-YXHZ-01
Plano para dados de participantes individuais (IPD)
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