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A Clinical Trial Evaluating the Combined Diagnostic Value of Electrocardiogram, Blood Pressure Variability, and Pressure Wave Analysis for Heart Failure

A Clinical Trial Evaluating the Combined Diagnostic Value of Electrocardiogram, Blood Pressure Variability, and Pressure Wave Analysis for Heart Failure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113932
Enrollment
Unknown
Registered
2025-12-04
Start date
2023-05-18
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Heart failure (HF)

Interventions

Gold Standard:Diagnosis results of 2 or more senior professional doctors with professional titles
Index test:1. An artificial intelligence algorithm developed based on blood pressure variability, pressure waves, electrocardiogram, and other parameters. 2. A comprehensive diagnostic model for hear

Sponsors

The 2nd Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, with independent cognitive ability, able to cooperate with the investigation; both male and female participants are included. 2. Able to undergo non-invasive physiological signal monitoring, including but not limited to ECG, body surface blood pressure, temperature, and other examinations. 3. Patients diagnosed with clinical heart failure or excluded from clinical heart failure based on initial clinical evaluation. (Note: This inclusion criterion refers to the initial clinical evaluation based on suspected heart failure symptoms. The final diagnosis of heart failure or non-heart failure will be determined through further expert evaluation, which will be conducted blinded to the initial classification.) 4. Patients must consent to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with electrocardiogram findings suggestive of ventricular fibrillation or ventricular tachycardia. 2. Electrical cardioversion or defibrillation performed within the preceding 7 days. 3. Ongoing blood purification therapy, extracorporeal membrane oxygenation (ECMO), or intra-aortic balloon pump (IABP) support. 4. Massive pericardial effusion or cardiac tamponade. 5. Bilateral upper-limb injuries precluding non-invasive blood pressure measurement. 6. Severe stenosis of brachial subclavian or brachial artery. 7. Inability to maintain a supine or semi-recumbent position required for signal acquisition. 8. Determination after enrolment that the participant did not meet inclusion criteria. 9. Occurrence of a serious adverse event that made continuation unsafe. 10. Patients or their legal guardians requesting withdrawal from the study. 11. Patients deemed unsuitable to continue the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive Predictive Value;Accuracy;Negative Predictive Value;Area Under the ROC Curve;

Countries

China

Contacts

Public ContactYang Pan

The Second Affiliated Hospital of Chongqing Medical University

tmmu_yp@126.com+86 23 63693127

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026