Application of Multimodal Large Language Model in HFpEF (MeG-HFpEF)

Peking University

Status: Enrolling

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Diagnostic Test: Multimodal Large Language Model Diagnosis; Diagnostic Test: Routine diagnostic and therapeutic procedure

Study type: Observational

Funder types: Other

Identifiers

NCT06486649

M2023830

Details and patient eligibility

About

This study will validate the effectiveness of a multimodal large language model to screen for heart failure with preserved ejection fraction (HFpEF), comparing it with the traditional clinical standardized assessment process.

Full description

Heart failure is a major complication of various heart diseases and is the leading lethal cause of cardiovascular death worldwide. Based on the left ventricular ejection fraction (LVEF), heart failure can be divided into heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF). Heart failure rehospitalization rates and in-hospital complications did not differ between HFrEF and HFpEF. However, over the past two decades, the survival rate of HFrEF has improved significantly, whereas HFpEF has remained stagnant. One of the major reasons for this is that the diagnostic process of HFpEF is complicated, and it is easy to cause missed diagnosis in the clinic, resulting in delayed treatment.

Multimodal large language models are capable of integrating and analyzing medical data from different sources, including textual data (e.g., medical records, medical literature), image data (e.g., electrocardiograms, CT scan images), and audio data (e.g., symptoms narrated by patients). This multimodal data integration capability is crucial for understanding complex medical scenarios, as it provides a more comprehensive view of the condition than a single data source.

The diagnosis of HFpEF faces many challenges and requires clinicians to make judgments on multi-dimensional data, which can easily lead to the underdiagnosis and misdiagnosis of the disease. As a generative artificial intelligence tool, a large language model is able to integrate and analyze data from different sources and has the ability to learn and evolve from existing clinical evidence. Based on this, this study intends to evaluate the effectiveness of multimodal large language model for screening for heart failure with preserved ejection fraction (HFpEF), comparing it with the traditional clinical standard assessment process.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80 years, male or female;
2. Cardiology inpatients with suspected heart failure with preserved ejection fraction (cardiac ultrasound suggestive of LVEF ≥50% with at least 1 of the following: 1, left ventricular hypertrophy and/or left atrial enlargement; and 2, abnormal diastolic cardiac function);
3. Current or previous at least one symptom of heart failure, including dyspnea (including exertional dyspnea, nocturnal paroxysmal dyspnea, and telangiectasia), malaise, nausea, and bilateral lower extremity edema;
4. Voluntary participation and signed informed consent.

Exclusion criteria

1. Acute heart failure or acute worsening of chronic heart failure;
2. Severe coronary stenosis (≥75% stenosis) without revascularization;
3. Patients who are unable to perform exercise stress echocardiography or have contraindications to the test;
4. are participating in other clinical trials;
5. Those with severe organic pathologies of the liver, kidney, or hematologic system or those with chronic diseases;
6. Those who are unable to follow the trial procedures;
7. Those who refuse to sign the informed consent.

Trial design

80 participants in 1 patient group

single group

Description:

The routine consultation process was performed first: according to the process recommended by the 2023 edition of the Chinese Expert Consensus on the Diagnosis and Treatment of Heart Failure with Preserved Ejection Fraction, the attending cardiologist completed the subject's clinical criteria assessment and performed the HFpEF diagnosis (yes/no). During the attending physician's checkup visit, the multimodal large language model screening system (MedGuide-72B) collected routine visit data, recorded relevant data and indicators during the patient's communication with MedGuide-72B and made the diagnosis.

Treatment:

Diagnostic Test: Routine diagnostic and therapeutic procedure

Diagnostic Test: Multimodal Large Language Model Diagnosis