- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05638230
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Minkwan Kim
- Phone Number: 823151898787 82-10-4187-0587
- Email: minkwan@yuhs.ac
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HIgh HFA-PEFF points (≥5)
|
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)
|
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)
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
Relative importance of left atrial reservoir strain
Time Frame: 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)
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9-2022-0101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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