Nyt bærbart apparat til behandling af hjertesvigt
Klinisk translationel forskning af nyt bærbart udstyr baseret på patenteret sensorteknologi i ikke-invasiv behandling af hjertesvigt
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Di Sun, Dr.
- Telefonnummer: 010-84206809
- E-mail: sundi0929@163.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Ingen indgriben: Control group
Patients receive a standard of care for heart failure without a wearable device. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Hospital Readmissions for Heart Failure
Tidsramme: Up to 6 months
|
Total hospitalizations for heart failure will be monitored via follow-up. |
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Concordance of the Jugular Vein Pressure with the RHC Measurement
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: Up to 6 months
|
Device/System-related Complications refer to adverse events such as device failure and allergy. |
Up to 6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjects Included the Endpoint of Cardiovascular Mortality
Tidsramme: 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
Tidsramme: Up to 6 months
|
Rate of all-cause mortality will be monitored via follow-up. |
Up to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022-NHLHCRF-YXHZ-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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