Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)
7 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
818
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Yihong Sun
- Numero di telefono: +86 15001251357
- Email: yihongsun72@163.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Solita cura
|
|
|
Sperimentale: Gruppo di Intervento Assistito da Dispositivo Indossabile
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Composite outcome of death or HF hospitalization
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in GDMT score
Lasso di tempo: 90 days after randomization
|
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.
|
90 days after randomization
|
|
NT-proBNP measures
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
|
|
Cardiovascular death
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
|
|
Stroke
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
|
|
Time to first readmission for heart failure (HF)
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
|
|
AF burden monitored by ECG straps
Lasso di tempo: 2 years after randomization
|
2 years after randomization
|
|
|
Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)
Lasso di tempo: 2 years after randomization
|
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.
|
2 years after randomization
|
|
Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)
Lasso di tempo: 2 years after randomization
|
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.
|
2 years after randomization
|
|
Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Lasso di tempo: 2 years after randomization
|
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.
|
2 years after randomization
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
30 dicembre 2028
Date di iscrizione allo studio
Primo inviato
25 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
30 giugno 2026
Primo Inserito (Effettivo)
7 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KS2026104
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .