Application of Multimodal Large Language Model in HFpEF

NCT06486649 | Recruiting DMC

• 1 other identifier: M2023830
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure with preserved ejection fraction; large language model; diagnosis

Outcome Measures

Primary Outcomes (2)

• dignostic specificity

  dianostic specificity comparison between routine diagnosis and therapy and large language model diagnosis

  through study completion, an average of 8 months

• dignostic sensitivity

  dianostic sensitivity comparison between routine diagnosis and therapy and large language model diagnosis

  through study completion, an average of 8 months

Secondary Outcomes (7)

• consistency rate

  through study completion, an average of 8 months

• time spent on diagnosis

  through study completion, an average of 8 months

• patient satisfaction

  through study completion, an average of 8 months

• economic cost analysis

  through study completion, an average of 8 months

• false discovery rate

  through study completion, an average of 8 months

Study Arms (1)

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.

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

Interventions

Multimodal Large Language Model Diagnosis DIAGNOSTIC_TEST

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

single group

Routine diagnostic and therapeutic procedure DIAGNOSTIC_TEST

Routine diagnostic and therapeutic procedure

single group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from patients routinely hospitalized in the cardiology department who also met the needs of this trial and are not recruited separately.

You may qualify if:

• Age 18-80 years, male or female;
• 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);
• 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;
• Voluntary participation and signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Tianjin Medical University General Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator
• Qianfoshan Hospital: collaborator
• Qingdao Municipal Hospital: collaborator

Study Sites (1)

Peking UniversityThird Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 37137593 BACKGROUND

• 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.

  PMID: 35789069 BACKGROUND

• 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.

  PMID: 35262693 BACKGROUND

• 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.

  PMID: 34379445 BACKGROUND

• 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.

  PMID: 36027566 BACKGROUND

• 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.

  PMID: 31976862 BACKGROUND

• 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.

  PMID: 32247333 BACKGROUND

• 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.

  PMID: 32956811 BACKGROUND

• 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.

  PMID: 31926855 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiangbin Meng

CONTACT

17600220171; 15896850171@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: July 3, 2024
• Study Start: December 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)