Atrial Fibrillation (AF)NCT07687862
Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)
A study of Atrial Fibrillation (AF) and Heart Failure and Reduced Ejection Fraction, run by Beijing Anzhen Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure and Reduced Ejection Fraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 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 3. 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 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.
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: 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.
- Being tested
- wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device-Assisted Intervention Group | Experimental | Not described Receives: Drug: wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF) |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of death or HF hospitalization
Measured: 2 years after randomization
Secondary outcomes (9)
Change in GDMT score
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.
Measured: 90 days after randomization
NT-proBNP measures
Measured: 2 years after randomization
Cardiovascular death
Measured: 2 years after randomization
Stroke
Measured: 2 years after randomization
Time to first readmission for heart failure (HF)
Measured: 2 years after randomization
AF burden monitored by ECG straps
Measured: 2 years after randomization
Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)
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.
Measured: 2 years after randomization
Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)
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.
Measured: 2 years after randomization
Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
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.
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- 818 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yihong Sun, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687862
- Sponsor's protocol ID
- KS2026104
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07687862
- Acronym / sponsor ID
- KS2026104
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 818 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 Jul 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.
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.
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 | Drug: wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF) |
| Usual Care | 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 3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting > 30 seconds on electrocardiogram [ECG] within the past 12 months)
Key exclusion criteria (8 listed)
- 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;
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 based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)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. | Drug | Wearable Device-Assisted Intervention Group |
Primary outcome
Composite outcome of death or HF hospitalization
Time frame: 2 years after randomization
9 secondary outcomes
Change in GDMT score
Time frame: 90 days after randomization
NT-proBNP measures
Time frame: 2 years after randomization
Cardiovascular death
Time frame: 2 years after randomization
Stroke
Time frame: 2 years after randomization
Time to first readmission for heart failure (HF)
Time frame: 2 years after randomization
AF burden monitored by ECG straps
Time frame: 2 years after randomization
Changes in quality of life (QoL) using Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)
Time frame: 2 years after randomization
Changes in Quality of life (QoL) using Minnesota Heart Failure Quality of Life Scale (MLHFO)
Time frame: 2 years after randomization
Changes in quality of life (QoL) using a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Time frame: 2 years 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 9 Jul 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 of Atrial Fibrillation (AF) and Heart Failure and Reduced Ejection Fraction, 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 8 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 9 Jul 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 Yihong Sun (+86 15001251357, yihongsun72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of death or HF hospitalization (time frame: 2 years 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 9 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.