Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Yihong Sun
- Telefonnummer: +86 15001251357
- E-post: yihongsun72@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Vanlig omsorg
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Eksperimentell: Intervensjonsgruppe med bærbar enhet
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Composite outcome of death or HF hospitalization
Tidsramme: 2 years after randomization
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2 years after randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in GDMT score
Tidsramme: 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
Tidsramme: 2 years after randomization
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2 years after randomization
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Cardiovascular death
Tidsramme: 2 years after randomization
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2 years after randomization
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Stroke
Tidsramme: 2 years after randomization
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2 years after randomization
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Time to first readmission for heart failure (HF)
Tidsramme: 2 years after randomization
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2 years after randomization
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AF burden monitored by ECG straps
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KS2026104
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