Fact CheckerSign in

NCT07010952Not yet recruiting

AI-based Echocardiographic Quantification in Heart Failure

Artificial Intelligence-based Automatic Echocardiographic Quantification in Advanced Heart Failure (AIED Study)

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Heart failure (HF) is a clinical complication. About half of HF patients have heart failure with normal systolic fraction (HFpEF), and most of them are elderly women. The other type is systolic heart failure, characterized by a left ventricular ejection fraction of less than 40 (LVEF\<40). The clinical symptoms of HFpEF are very similar to those of low systolic fraction heart failure (HFrEF) with abnormal left ventricular ejection fraction. Generally speaking, the morbidity and severity of HFrEF are higher, and the survival rate is lower. HFpEF is generally difficult to diagnose, so it is critical to find a method to accurately diagnose HFpEF. HFpEF is most commonly diagnosed by echocardiography and biomarkers. In a cardiac ultrasound examination, it is impossible to diagnose HFpEF based on a single parameter of the results. We need multiple examination parameters to gather enough evidence to confirm the existence of HFpEF. These parameters include the mitral inflow velocity pattern, the pulmonary vein flow pattern, changes in flow velocity from the left atrium to the left ventricle, tissue Doppler measurements, and M-mode ultrasound measurements. We train artificial intelligence to distinguish between normal and abnormal cardiac ultrasound images, measure or evaluate all the above parameters, and analyze all the data. We hope that, with the help of artificial intelligence, we can improve the prediction and diagnosis rate of HFpEF. Simply diagnosing HFrEF requires an LVEF of less than 40%. Diagnosing HFpEF poses significant clinical challenges because no single tool or method can reliably confirm the condition or predict associated hospitalizations. Consequently, diagnosis depends heavily on physician judgment, requiring the synthesis of considerable clinical data and information. Recognizing the heterogeneity of the HFpEF phenotype, phenomapping integrates comprehensive data (clinical history, physiological measurements, biomarkers, ECG, echocardiographic parameters) to stratify patients into distinct subtypes, thereby optimizing classification for improved prognostic prediction. It can be seen from this that HF will rely heavily on artificial intelligence in the future to assist in patient data management and classification diagnosis and further develop clinical prediction models. This research project will implement a multi-center design to collect ultrasound images from patients with heart failure and perform relevant analyses using artificial intelligence.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
30 May 2025
Start date
1 Jul 2025
Primary completion date
1 Dec 2025
Lead sponsor
Mackay Memorial Hospital
NCT number
NCT07010952

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 1 Jul 2025 to the primary completion date, 1 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Congenital heart disease, hypertrophic cardiomyopathy, restrictive or constrictive pericardial pathology, or prior cardiac transplantation/LVAD.
  • Concurrent enrollment in another interventional trial that may confound results of imaging or biomarkers.

Other illness

  • Significant native or prosthetic valvular heart disease (moderate-to-severe) requiring surgery or trans-catheter therapy.

Lab values

  • Mid-range LVEF 40-49 %.

Other

  • Inadequate echocardiographic image quality (e.g., missing views, severe acoustic shadowing) precludes automated analysis.
  • Hemodynamic instability preventing standardized imaging or data collection.
  • Pregnancy.

Who the study is looking for

  • Age ≥ 18 years.
  • Admission for acute or chronic heart failure between January 1, 2017, and April 30, 2024.
  • Transthoracic echocardiography completed ≤ 48 h after admission with diagnostic-quality DICOM cine loops (parasternal long/short axis and apical 2-/3-/4-chamber views plus Doppler and tissue Doppler).
  • Meets one of the two predefined phenotypes:
    • HFpEF: LVEF ≥ 50 % + typical HF signs/symptoms + objective diastolic dysfunction.
    • HFrEF: LVEF \< 40 % in keeping with guideline-defined systolic HF.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.