HFrEF - Heart Failure With Reduced Ejection FractionWARM-HFNCT07411170
Wearable Device-Assisted Remote Management in Atrial Fibrillation Complicated by Heart Failure: WARM-HF Trial
A study testing Wearable Device-Assisted Intervention in people with HFrEF - Heart Failure With Reduced Ejection Fraction and AF - Atrial Fibrillation, run by Beijing Anzhen Hospital.
Trial summary
Patients with acute decompensated heart failure (HF) have a significantly high risk of death and HF re-hospitalization during the vulnerable phase post discharge. Therefore, early post-discharge management is crucial, and the cornerstone of HF treatment-particularly for HF with reduced ejection fraction (HFrEF)-is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, AF - Atrial Fibrillation
- What is being tested?
- Wearable Device-Assisted Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting > 30 seconds on electrocardiogram [ECG] within the past 12 months)
Who cannot join
- Intolerance to heart failure pharmacotherapy
- Severe anemia, uncorrected thyroid disease
- ST-segment elevation myocardial infarction (STEMI) within 3 months
- Known complex congenital/secondary heart disease; infiltrative cardiomyopathy (e.g., cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy (Takotsubo cardiomyopathy); or uncorrected primary valvular heart disease requiring surgical intervention.
- Previous or planned major cardiac surgery or mechanical circulatory support 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.
- Current use of or planned implantation of a pacemaker.
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- Contraindications to wearing a smartwatch (e.g., limb disability or known allergy to rubber/metal materials)
- Inability to access the Internet or lack of proficiency in operating smart devices
- Pregnant or lactating women
- Organ transplantation within the past 12 months
- Expected survival time of less than 1 year for any reason
- Refusal to participate or inability to comply with follow-up requirements
- Deemed ineligible for participation in the study by the investigators
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Wearable Device-assisted Remote Management for Patients With Atrial Fibrillation Complicated by Heart Failure: A Prospective, Open-label, Multi-center, Randomized Controlled Trial
Patients with acute decompensated heart failure (HF) have a significantly high risk of death and HF re-hospitalization during the vulnerable phase post discharge. Therefore, early post-discharge management is crucial, and the cornerstone of HF treatment-particularly for HF with reduced ejection fraction (HFrEF)-is guideline-directed medical therapy (GDMT), a comprehensive pharmacotherapeutic strategy supported by robust clinical evidence. Timely titration of GDMT, especially within the first few weeks after discharge, has been shown to improve clinical outcomes, reduce readmissions, and enhance long-term prognosis. However, ensuring optimal follow-up and therapeutic adjustments remains a major challenge in real-world practice. Atrial fibrillation (AF) is a common comorbidity in patients with HF, especially in those with severe HF. The presence of AF significantly complicates the clinical course and worsens the prognosis of HF.
Advances in wearable technology have made continuous, non-invasive monitoring of vital signs, arrhythmia burden, and physical status increasingly feasible. Devices such as smartwatches and ECG belts can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such data, the complex interplay between AF and HF demands highly personalized management. Currently, there is a lack of high-quality clinical evidence on how to effectively integrate wearable device data into personalized strategies for this specific patient population.
Read more
This is an open-label, multi-center, endpoint-blinded, parallel-group randomized clinical trial supported by the American Heart Association. The primary objective is to determine whether wearable device-assisted digital consultations can optimize GDMT in patients with AF complicated by acute decompensated HF. The study plans to enroll 400 participants, who will be randomly assigned to either a wearable device-assisted intervention group or a conventional treatment control group. The primary endpoint is the change in HF GDMT score 3 months after randomization.
Apple Inc. provided funding, devices, and technical support for this study. Apple was not a sponsor of the trial and was not involved in its execution, data analysis, interpretation, or manuscript preparation.
- Being tested
- Wearable Device-Assisted Intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device-Assisted InterventionOther
This intervention comprises two core components: (A) A data collecting system via smartwatch and ECG belt; and (B) A decision-support algorithms for risk stratification and medication dose adjustment based on real-time data.
Participants will be instructed to wear both the Apple Watch and ECG belt for a minimum of 12-18 hours per day to monitor parameters, such as heart rhythm and respiratory rate. Participants will be prompted via the research APP to complete questionnaires for symptom, blood pressure, and body weight data. All collected data are automatically uploaded to a secure cloud-based platform. A centralized decision-support system analyzes the integrated information using a suite of predefined, multi-layered algorithms to identify patients requiring intervention. Patients will be stratified into three tiers based on integrated physiological metrics and symptom reports: Normal subgroup, Abnormal subgroup, and E-alarm subgroup.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device-Assisted Intervention Group | Experimental | Not described Receives: Other: Wearable Device-Assisted Intervention |
| Conventional Treatment Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart Failure Guideline-directed Medical Therapy (GDMT) Score
High score favorable
Measured: 3 Months After Randomization
Secondary outcomes (3)
AF recurrence monitored by Apple Watch and ECG belt
Measured: 3 Months After Randomization
AF burden monitored by ECG belt
Measured: 12 Months After Randomization
Time to first HF hospitalization and/or cardiovascular death
Measured: 12 Months After Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411170
- Sponsor's protocol ID
- KS2025250
- Acronym
- WARM-HF
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device-assisted Remote Management for Patients With Atrial Fibrillation Complicated by Heart Failure: A Prospective, Open-label, Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07411170
- Acronym / sponsor ID
- WARM-HF / KS2025250
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with acute decompensated heart failure (HF) have a significantly high risk of death and HF re-hospitalization during the vulnerable phase post discharge. Therefore, early post-discharge management is crucial, and the cornerstone of HF treatment-particularly for HF with reduced ejection fraction (HFrEF)-is guideline-directed medical therapy (GDMT), a comprehensive pharmacotherapeutic strategy supported by robust clinical evidence. Timely titration of GDMT, especially within the first few weeks after discharge, has been shown to improve clinical outcomes, reduce readmissions, and enhance long-term prognosis. However, ensuring optimal follow-up and therapeutic adjustments remains a major challenge in real-world practice. Atrial fibrillation (AF) is a common comorbidity in patients with HF, especially in those with severe HF. The presence of AF significantly complicates the clinical course and worsens the prognosis of HF.
Advances in wearable technology have made continuous, non-invasive monitoring of vital signs, arrhythmia burden, and physical status increasingly feasible. Devices such as smartwatches and ECG belts can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such data, the complex interplay between AF and HF demands highly personalized management. Currently, there is a lack of high-quality clinical evidence on how to effectively integrate wearable device data into personalized strategies for this specific patient population.
This is an open-label, multi-center, endpoint-blinded, parallel-group randomized clinical trial supported by the American Heart Association. The primary objective is to determine whether wearable device-assisted digital consultations can optimize GDMT in patients with AF complicated by acute decompensated HF. The study plans to enroll 400 participants, who will be randomly assigned to either a wearable device-assisted intervention group or a conventional treatment control group. The primary endpoint is the change in HF GDMT score 3 months after randomization.
Apple Inc. provided funding, devices, and technical support for this study. Apple was not a sponsor of the trial and was not involved in its execution, data analysis, interpretation, or manuscript preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Device-Assisted Intervention Group | Experimental | Other: Wearable Device-Assisted Intervention |
| Conventional Treatment Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting > 30 seconds on electrocardiogram [ECG] within the past 12 months)
Key exclusion criteria (13 listed)
- Intolerance to heart failure pharmacotherapy
- Severe anemia, uncorrected thyroid disease
- ST-segment elevation myocardial infarction (STEMI) within 3 months
- Known complex congenital/secondary heart disease; infiltrative cardiomyopathy (e.g., cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy (Takotsubo cardiomyopathy); or uncorrected primary valvular heart disease requiring surgical intervention.
- Previous or planned major cardiac surgery or mechanical circulatory support 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Device-Assisted InterventionThis intervention comprises two core components: (A) A data collecting system via smartwatch and ECG belt; and (B) A decision-support algorithms for risk stratification and medication dose adjustment based on real-time data. Participants will be instructed to wear both the Apple Watch and ECG belt for a minimum of 12-18 hours per day to monitor parameters, such as heart rhythm and respiratory rate. Participants will be prompted via the research APP to complete questionnaires for symptom, blood pressure, and body weight data. All collected data are automatically uploaded to a secure cloud-based platform. A centralized decision-support system analyzes the integrated information using a suite of predefined, multi-layered algorithms to identify patients requiring intervention. Patients will be stratified into three tiers based on integrated physiological metrics and symptom reports: Normal subgroup, Abnormal subgroup, and E-alarm subgroup. | Other | Wearable Device-Assisted Intervention Group |
Primary outcome
Changes in Heart Failure Guideline-directed Medical Therapy (GDMT) Score
Time frame: 3 Months After Randomization
High score favorable
3 secondary outcomes
AF recurrence monitored by Apple Watch and ECG belt
Time frame: 3 Months After Randomization
AF burden monitored by ECG belt
Time frame: 12 Months After Randomization
Time to first HF hospitalization and/or cardiovascular death
Time frame: 12 Months After Randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device-Assisted Intervention in people with HFrEF - Heart Failure With Reduced Ejection Fraction and AF - Atrial Fibrillation, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyao Wei, MD., PhD. (010-15521192379, weizhiyaoyx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Heart Failure Guideline-directed Medical Therapy (GDMT) Score (time frame: 3 Months After Randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.