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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06070506
Other study ID # 2020020668
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date May 20, 2023

Study information

Verified date October 2023
Source First Affiliated Hospital of Harbin Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to design a deep learning-based trained model to assist in HFimpEF diagnosis.


Recruitment information / eligibility

Status Completed
Enrollment 422
Est. completion date May 20, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age >18 years. 2. The diagnostic criteria of HF follows the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, having symptoms of dyspnea, fatigue or decreased activity tolerance, having signs of fluid retention (such as pulmonary congestion and peripheral edema), having echocardiogram abnormalities in cardiac structure and/or function, showing elevated natriuretic peptide levels (BNP>35 ng/L or/and N-terminal pro-BNP >125 ng/L). 3. Have reviewing echocardiography after discharge. Exclusion Criteria: 1. Patients with hypertrophic, restrictive, or invasive cardiomyopathy and congenital or rheumatic heart disease. 2. Patients with heart transplantation during follow-up.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yihui Kong Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Yihui Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of left ventricular ejection fraction left ventricular ejection fraction value in millimeters 3 months
Secondary change of clinical predictor of EF improvement weight in kilograms, height in meters(weight and height will be combined to report BMI in kg/m^2) 3 months
Secondary the independent clinical predictor of HFimpEF prealbumin in mg/L 3 months
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