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

NCT05638230 | Unknown

• 1 other identifier: 9-2022-0101
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Diastolic; Heart Failure, Preserved Ejection Fraction

Keywords

left atrial reservoir strain; HFA-PEFF; LA strain; Heart failure with preserved ejection fraction (HFpEF)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

HIgh HFA-PEFF points (≥5)

Diagnostic Test: Left atrial reservoir strain

Low to intermediate HFA-PEFF points (<5)

Diagnostic Test: Left atrial reservoir strain

Interventions

Left atrial reservoir strain DIAGNOSTIC_TEST

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.

HIgh HFA-PEFF points (≥5); Low to intermediate HFA-PEFF points (<5)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Minkwan Kim

Yongin, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (1)

• Kim M, Bae S, Park JH, Jung IH. Relative importance of left atrial reservoir strain compared with components of the HFA-PEFF score: a cross-sectional study. Front Cardiovasc Med. 2023 Oct 12;10:1213557. doi: 10.3389/fcvm.2023.1213557. eCollection 2023.

  PMID: 37900564 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Minkwan Kim

CONTACT

82-10-4187-0587; minkwan@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 6, 2022
• Study Start: August 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2025
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)