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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure, Diastolic; Heart Failure, Preserved Ejection Fraction
• Intervention / Treatment: Diagnostic test: Left atrial reservoir strain

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Minkwan Kim; Phone Number: 823151898787 82-10-4187-0587; Email: minkwan@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Yongin, Gyeonggi, Korea, Republic of, 16995
      • Recruiting
      • Minkwan Kim
      • Contact: Minkwan Kim; Phone Number: 821041870587; Email: minkwan@yuhs.ac
      • Contact: Yoohee Kim; Phone Number: 823151899659 82-10-8479-7203; Email: YOUHEE2022@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited a cardiovascular center clinic for dyspnea and chest discomfort and who underwent echocardiography were enrolled for participants suspected of having heart failure with preserved ejection fraction.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5)	Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5) in multiple linear regression analysis.	through study completion, an average of 1 year
Relative importance of left atrial reservoir strain	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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 26, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: left atrial reservoir strain; HFA-PEFF; LA strain; Heart failure with preserved ejection fraction (HFpEF)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Heart Failure; Heart Failure, Diastolic; Sprains and Strains
• Other Study ID Numbers: 9-2022-0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No