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Lo studio clinico NCT07352891 (DigiCare-HFrEF) per Insufficienza Cardiaca con Frazione di Eiezione Ridotta è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Improve Prognosis in Patients With Heart Failure With Reduced Ejection Fraction (DigiCare-HFrEF) 774 In aperto Iniziato dallo sperimentatore Remoto
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La sperimentazione clinica NCT07352891 (DigiCare-HFrEF) è uno studio interventistico per Insufficienza Cardiaca con Frazione di Eiezione Ridotta, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 gennaio 2026, con l'obiettivo di raggiungere 774 partecipanti. Sotto la guida di Chang sheng Ma, dovrebbe concludersi entro il 1 luglio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 gennaio 2026.
Sommario breve
DigiCare-HFrEF is an investigator-initiated, multicentre, randomised, open-label, endpoint-blinded, superiority trial designed to evaluate whether a structured digital remote-management platform can improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFrEF) after hospital discharge. Eligible adults with LVEF ≤40% within past 3 months, NYHA class II-IV, and elevated natriuretic pep...Mostra di più
Descrizione dettagliata
"Heart failure with reduced ejection fraction (HFrEF) remains associated with high rates of early post-discharge events. In routine practice, timely optimisation of guideline-directed medical therapy (GDMT) and early recognition of haemodynamic deterioration are frequently limited by infrequent follow-up, delayed access to physiologic data, and variability in patient self-management.
DigiCare-HFrEF will enroll hospi...
Mostra di piùTitolo ufficiale
Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Improve Prognosis in Patients With Heart Failure With Reduced Ejection Fraction (DigiCare-HFrEF): A Multicentre, Randomised, Controlled Trial
Patologie
Insufficienza Cardiaca con Frazione di Eiezione RidottaAltri ID dello studio
- DigiCare-HFrEF
- KS2025289
Numero NCT
Data di inizio (effettiva)
2026-01
Ultimo aggiornamento pubblicato
2026-01-20
Data di completamento (stimata)
2027-07
Arruolamento (previsto)
774
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Nessun interventoUsual Care Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided. | N.D. |
SperimentaleDigital Remote Management Participants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendat...Mostra di più | Digital Remote Management Participants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendat...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Composite of cardiovascular death or first heart failure event | hospitalisation or urgent visit for heart failure | 12 months after randomization |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months | The Guideline-Directed Medical Therapy (GDMT) Score is a modified heart-failure pharmacotherapy score based on five medication classes:
1. angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB),
2. angiotensin receptor-neprilysin inhibitor (ARNI),
3. beta-blockers (BB),
4. mineralocorticoid receptor antagonists (MRA), and
5. sodium-glucose cotransporter-2 inhibitors (SGLT2i).
Dosing levels are scored as follows:
* ACEi/ARB: 0 = none; 0 = \<50% target dose; 1 = ≥50% target dose.
* ARNI: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose.
* Beta-blocker: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose.
* MRA: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose.
* SGLT2 inhibitor: 0 = none; 2 = therapeutic dose (no low-dose category). The total GDMT Score ranges from 0 to 9, with higher scores indicating more complete, optimized, and guideline-concordant HF medical therapy. | 3 months after randomization |
First heart failure hospitalization | 3 months after randomization | |
First urgent visit for heart failure | 3 months after randomization | |
Total heart failure hospitalizations | 3 months after randomization | |
Total urgent visits for heart failure | 3 months after randomization | |
First cardiovascular hospitalization | 3 months after randomization | |
First all-cause hospitalization | 3 months after randomization | |
All-cause mortality | 3 months after randomization | |
First heart failure hospitalization | 12 months after randomization | |
First urgent visit for heart failure | 12 months after randomization | |
Total heart failure hospitalizations | 12 months after randomization | |
Total urgent visits for heart failure | 12 months after randomization | |
First cardiovascular hospitalization | 12 months after randomization | |
First all-cause hospitalization | 12 months after randomization | |
All-cause mortality | 12 months after randomization | |
Change in NT-proBNP from baseline | 12 months after randomization | |
Change in functional capacity (6-minute walk distance) | 12 months after randomization | |
Change in KCCQ score | The Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) is a 23-item patient-reported outcome measure of heart-failure-specific health status (symptoms, physical and social limitations, and quality of life). Each item is rated on a 5-point Likert scale (1 = extremely limited to 5 = not at all limited; response options such as "limited for other reasons or did not do this activity" are treated as missing). Domain scores are transformed to a 0-100 scale, and the overall summary score ranges from 0 to 100, with higher scores indicating better health status and fewer symptoms. | 12 months after randomization |
Change in MLHFQ score | The Minnesota Living With Heart Failure Questionnaire (MLHFQ) is a 21-item instrument assessing heart-failure-related quality of life. Each item is scored from 0 ("no impact") to 5 ("very much"). The total score ranges from 0 to 105, with higher scores indicating worse quality of life. | 12 months after randomization |
Change in EQ-5D-5L score | The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) describes health status in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 5 levels (1 = no problems to 5 = extreme problems). A utility index score is derived using the Chinese value set, with values ranging approximately from -0.281 to 1.000, and an accompanying visual analogue scale (VAS) score ranging from 0 to 100, where higher scores on both the index and the VAS indicate better health status. | 12 months after randomization |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Adults aged ≥18 years.
- Hospitalised at a secondary or tertiary hospital with established heart failure care capacity.
- Diagnosed with HFrEF within the past 3 months according to the 2022 ACC/AHA/HFSA guideline diagnostic pathway, including: LVEF ≤40% by echocardiography; typical heart-failure symptoms and/or signs; and exclusion of non-HF causes of symptoms.
- NT-proBNP >2500 pg/mL or BNP >600 pg/mL.
- NYHA functional class II-IV.
- Written informed consent provided."
- Absolute contraindication to heart failure pharmacotherapy.
- History of heart transplantation or currently on a transplant waiting list.
- Receiving or planning implantation of a left ventricular assist device.
- Pregnant or breastfeeding women.
- Organ transplantation within the past 12 months.
- Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).
- Unable to perform blood pressure or body-weight monitoring (e.g., severe limb disability).
- Unable to express willingness or comply with follow-up requirements (e.g., unable to use internet-enabled devices).
- Estimated life expectancy <1 year.
- Any other condition judged by the investigator to make the patient unsuitable for participation."
Chang sheng MaParte responsabile dello studio
Chang sheng Ma, Promotore-investigatore, Director of cardiology department, Beijing Anzhen Hospital
Contatti principali dello studio
Contatto: DigiCare-HFrEF Coordinating Center, [email protected], [email protected]
6 Centri dello studio in 1 paesi
Beijing Anzhen Hospital, Capital Medical University, Beijing, China, Beijing, China
Beijing Tongren Hospital, Capital Medical University, Beijing, China, Beijing, China
The First Affiliated Hospital of Dalian Medical University, Dalian, China, Dalian, China
The First Hospital of Jilin University, Changchun, China, Jilin, China
The Second Affiliated Hospital of Nanchang University, Nanchang, China, Nanchang, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Shanghai, China