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

Heart Failure, Diastolic Clinical Trial

— RICH-LAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638230
• Other study ID #: 9-2022-0101
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: Minkwan Kim
• Phone: 82-10-4187-0587
• Email: minkwan[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Sprains and Strains

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Minkwan Kim	Yongin	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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