Application of Multimodal Large Language Model in HFpEF

NCT ID: NCT06486649

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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single group

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.

Multimodal Large Language Model Diagnosis

Intervention Type DIAGNOSTIC_TEST

Diagnosis for heart failure with preserved ejection fraction (HFpEF) using the multimodal large language model MedGuide-72B.

Routine diagnostic and therapeutic procedure

Intervention Type DIAGNOSTIC_TEST

Routine diagnostic and therapeutic procedure

Interventions

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Multimodal Large Language Model Diagnosis

Diagnosis for heart failure with preserved ejection fraction (HFpEF) using the multimodal large language model MedGuide-72B.

Intervention Type DIAGNOSTIC_TEST

Routine diagnostic and therapeutic procedure

Routine diagnostic and therapeutic procedure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Qingdao Municipal Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tang Yida

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking UniversityThird Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangbin Meng

Role: CONTACT

17600220171

References

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Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available.

Reference Type BACKGROUND
PMID: 37137593 (View on PubMed)

Wang X, Cunningham JW. Restoring balance in heart failure with preserved ejection fraction. Eur J Heart Fail. 2022 Aug;24(8):1415-1417. doi: 10.1002/ejhf.2599. Epub 2022 Jul 18. No abstract available.

Reference Type BACKGROUND
PMID: 35789069 (View on PubMed)

Sicari R. Phenotyping heart failure with preserved ejection fraction with exercise stress echocardiography. Eur Heart J Cardiovasc Imaging. 2022 Jul 21;23(8):1053-1054. doi: 10.1093/ehjci/jeac053. No abstract available.

Reference Type BACKGROUND
PMID: 35262693 (View on PubMed)

Omote K, Verbrugge FH, Borlaug BA. Heart Failure with Preserved Ejection Fraction: Mechanisms and Treatment Strategies. Annu Rev Med. 2022 Jan 27;73:321-337. doi: 10.1146/annurev-med-042220-022745. Epub 2021 Aug 11.

Reference Type BACKGROUND
PMID: 34379445 (View on PubMed)

Margulies KB. DELIVERing Progress in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1138-1140. doi: 10.1056/NEJMe2210177. Epub 2022 Aug 27. No abstract available.

Reference Type BACKGROUND
PMID: 36027566 (View on PubMed)

Ventura HO, Lavie CJ, Mehra MR. Heart Failure With Preserved Ejection Fraction: Separating the Wheat From the Chaff. J Am Coll Cardiol. 2020 Jan 28;75(3):255-257. doi: 10.1016/j.jacc.2019.11.027. No abstract available.

Reference Type BACKGROUND
PMID: 31976862 (View on PubMed)

Reddy YNV, Borlaug BA. Heart Failure With Preserved Ejection Fraction: Where Do We Stand? Mayo Clin Proc. 2020 Apr;95(4):629-631. doi: 10.1016/j.mayocp.2020.02.015. No abstract available.

Reference Type BACKGROUND
PMID: 32247333 (View on PubMed)

Donal E, L'official G, Kosmala W. Heart Failure With Preserved Ejection Fraction: Defining Phenotypes. J Card Fail. 2020 Nov;26(11):929-931. doi: 10.1016/j.cardfail.2020.09.013. Epub 2020 Sep 19. No abstract available.

Reference Type BACKGROUND
PMID: 32956811 (View on PubMed)

Ahmad T, Desai NR, Januzzi JL. Heart Failure With Preserved Ejection Fraction: Many Emperors With Many Clothes. JACC Heart Fail. 2020 Mar;8(3):185-187. doi: 10.1016/j.jchf.2019.11.004. Epub 2020 Jan 8. No abstract available.

Reference Type BACKGROUND
PMID: 31926855 (View on PubMed)

Other Identifiers

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M2023830

Identifier Type: -

Identifier Source: org_study_id

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