Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain

Recruiting

• Conditions: Heart Failure, Preserved Ejection Fraction; Heart Failure, Diastolic
• Interventions: Diagnostic Test: Left atrial reservoir strain

• Registration Number: NCT05638230
• Lead Sponsor: Yonsei University

Brief Summary

The goal of this observational study is to learn about left atrial reservoir strain in patients with heart failure with preserved ejection fraction. The main questions it aims to answer are:

* Usefullness of LARS as a predictor of high HFA-PEFF diagnostic algorithm scores (≥5)

* The relative importance of LARS in variables including each component of HFA-PEFF and traditional cardiovascular risk factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-10-24
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-26
• Last Update Submitted: 2022-11-26
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Participants with ICD-10 code of heart failure (I50) from August 2021 to July 2022
• 20-year-old or higher age
• Participants who are available to measure left atrial reservoir strain

Exclusion Criteria

• Left ventricular ejection fraction <50%
• Supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia)
• Participants who are given pacemaker or ICD implantation procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low to intermediate HFA-PEFF points (<5)	Left atrial reservoir strain	-
HIgh HFA-PEFF points (≥5)	Left atrial reservoir strain	-

Primary Outcome Measures

Name	Time	Method
Relative importance of left atrial reservoir strain	through study completion, an average of 1 year	Relative importance of left atrial reservoir strain among variables, including component of HFA-PEFF score, using supervised machine learning algorithm (random forest analysis) to estimate high HFA-PEFF score (≥5). LA reserver strain was measured using Automated Functional Imaging (AFI) of the left atrium 3.0 version (GE Healthcare)
Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5)	through study completion, an average of 1 year	Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5) in multiple linear regression analysis.

Trial Locations

Locations (1)

Minkwan Kim; 🇰🇷 Yongin, Gyeonggi, Korea, Republic of