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Wearable Sensor-Based Assessment of Seismocardiography-Electrocardiography Exercise Reactivity and Its Association with Clinical Outcomes in Patients with Heart Failure

Wearable Sensor-Based Assessment of Seismocardiography-Electrocardiography Exercise Reactivity and Its Association with Clinical Outcomes in Patients with Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100560
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Sponsors

Liyang Branch of Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 - 75 years old; 2. Inpatient or outpatient patients with heart failure, NYHA Class I-III; 3. Natriuretic peptide levels meet any of the following conditions: (1) BNP >= 150 pg/mL or NT-proBNP >= 600 pg/mL; (2) BNP >= 100 pg/mL or NT-proBNP >= 400 pg/mL if the patient has been hospitalized for heart failure within 12 months prior to enrollment; (3) BNP >= 300 pg/mL or NT-proBNP >= 900 pg/mL if the baseline ECG is present in a patient with atrial fibrillation or atrial flutter, regardless of whether they have a history of hospitalization for heart failure; 4. Those who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.6-minute walk test contraindicated; Absolute contraindications: uncontrolled acute coronary syndrome, acute heart failure, symptomatic severe aortic stenosis, severe coarctation of the aorta or descending aortic aneurysm, acute aortic dissection, acute myocarditis, pericarditis or endocarditis, symptomatic or hemodynamically unstable arrhythmias, acute deep vein thrombosis of the lower extremities, acute pulmonary embolism and pulmonary infarction, acute respiratory failure, uncontrolled asthma, acute infectious diseases, acute liver and kidney failure, mental abnormalities that cannot cooperate; Relative contraindications: known stenosis or occlusion of more than 50% of the left coronary artery, moderate to severe aortic stenosis without clear symptoms, bradyarrhythmia or atrioventricular block of grade or above, hypertrophic obstructive cardiomyopathy, severe pulmonary hypertension, resting heart rate > 120 beats/min, uncontrolled high blood pressure (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg), recent stroke or transient ischemic attack, intraatrial thrombosis, uncorrected clinical conditions (eg, severe anemia, electrolyte disorders, hyperthyroidism, etc.), peripheral SpO2 <85% at rest, walking dysfunction; 2. Patients with severe valvular heart disease or large pericardial effusion; 3. Those with a history of artificial heart valve implantation; 4. Those with a history of pacemaker implantation; 5. Patients with chronic obstructive pulmonary disease and other serious lung diseases; 6. Those with malignant tumors; 7. Those with peripheral or cerebrovascular diseases or musculoskeletal diseases that restrict physical activity; 8. Patients who are expected to undergo cardiovascular revascularization therapy (including percutaneous intervention or surgery) or major cardiac surgery within three months, including coronary artery bypass grafting, heart valve replacement, ventricular assist device implantation, heart transplantation, any surgery requiring thoracotomy, transcatheter aortic valve replacement or cardiac resynchronization therapy, etc.; 9. Those who are unable to cooperate with the completion of the baseline 6MWT; 10. Follow-up compliance may be poor and other clinical discretion exclusions by researchers.

Design outcomes

Primary

MeasureTime frame
The composite endpoint of worsening heart failure (WHF) requiring hospitalization or emergency department visit with intravenous diuretic therapy, or cardiovascular death;

Secondary

MeasureTime frame
Changes in NT-proBNP levels;Change in left ventricular ejection fraction (LVEF);Change in NYHA functional class;Change in 6-minute walk distance (6MWD);All cause death;

Countries

China

Contacts

Public ContactJunhong Wang

The First Affiliated Hospital With Nanjing Medical University

wangjunhong@jsph.org.cn+86 139 1473 2873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026