Nouveau dispositif portable pour la gestion de l'insuffisance cardiaque
Recherche clinique translationnelle sur un nouveau dispositif portable basé sur une technologie de détection brevetée dans la gestion non invasive de l'insuffisance cardiaque
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Di Sun, Dr.
- Numéro de téléphone: 010-84206809
- E-mail: sundi0929@163.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Aucune intervention: Control group
Patients receive a standard of care for heart failure without a wearable device. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Hospital Readmissions for Heart Failure
Délai: Up to 6 months
|
Total hospitalizations for heart failure will be monitored via follow-up. |
Up to 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Concordance of the Jugular Vein Pressure with the RHC Measurement
Délai: 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)
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: Up to 6 months
|
Device/System-related Complications refer to adverse events such as device failure and allergy. |
Up to 6 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subjects Included the Endpoint of Cardiovascular Mortality
Délai: 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
Délai: Up to 6 months
|
Rate of all-cause mortality will be monitored via follow-up. |
Up to 6 months
|
Collaborateurs et enquêteurs
Parrainer
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
- 2022-NHLHCRF-YXHZ-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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