RICH-LAST: Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05638230

Collaborator

(none)

2,500

Enrollment

Location

Anticipated Duration (Months)

52.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic Heart Failure, Preserved Ejection Fraction	Diagnostic Test: Left atrial reservoir strain

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
HIgh HFA-PEFF points (≥5)	Diagnostic Test: Left atrial reservoir strain LA strain measurements can be obtained by two dimensional (2D) speckle tracking echocardiography (STE). Longitudinal strain and strain rate curves are generated for each of six atrial segments, obtained from the apical four and two chamber views. In the reservoir phase, as the LA fills and stretches, there is positive atrial strain that reaches its peak in systole at the end of LA filling, prior to opening of the mitral valve. Following this, passive LA emptying ensues with opening of the mitral valve resulting in decreased atrial strain with negative deflection of the strain curve up to a plateau period which is analogous to diastasis. LA reservoir strain (LARS), or peak atrial longitudinal strain or LA systolic strain, is measured at the end of the reservoir phase.
Low to intermediate HFA-PEFF points (<5)	Diagnostic Test: Left atrial reservoir strain LA strain measurements can be obtained by two dimensional (2D) speckle tracking echocardiography (STE). Longitudinal strain and strain rate curves are generated for each of six atrial segments, obtained from the apical four and two chamber views. In the reservoir phase, as the LA fills and stretches, there is positive atrial strain that reaches its peak in systole at the end of LA filling, prior to opening of the mitral valve. Following this, passive LA emptying ensues with opening of the mitral valve resulting in decreased atrial strain with negative deflection of the strain curve up to a plateau period which is analogous to diastasis. LA reservoir strain (LARS), or peak atrial longitudinal strain or LA systolic strain, is measured at the end of the reservoir phase.

Arm

Intervention/Treatment

HIgh HFA-PEFF points (≥5)

Diagnostic Test: Left atrial reservoir strain

LA strain measurements can be obtained by two dimensional (2D) speckle tracking echocardiography (STE). Longitudinal strain and strain rate curves are generated for each of six atrial segments, obtained from the apical four and two chamber views. In the reservoir phase, as the LA fills and stretches, there is positive atrial strain that reaches its peak in systole at the end of LA filling, prior to opening of the mitral valve. Following this, passive LA emptying ensues with opening of the mitral valve resulting in decreased atrial strain with negative deflection of the strain curve up to a plateau period which is analogous to diastasis. LA reservoir strain (LARS), or peak atrial longitudinal strain or LA systolic strain, is measured at the end of the reservoir phase.

Low to intermediate HFA-PEFF points (<5)

Diagnostic Test: Left atrial reservoir strain

Outcome Measures

Primary Outcome Measures

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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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