Heart Failure, DiastolicRICH-LASTNCT05638230
Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain
An observational study of Heart Failure, Diastolic and Heart Failure, Preserved Ejection Fraction, run by Yonsei University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Heart Failure, Preserved Ejection Fraction
- What is being tested?
- Left atrial reservoir strain
- How many people
- 2,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 31 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Left ventricular ejection fraction <50%
- Supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia)
- Participants who are given pacemaker or ICD implantation procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Minkwan Kim
Yongin, Gyeonggi-do, 16995
Minkwan Kim, 821041870587, minkwan@yuhs.ac
Yoohee Kim, 82-10-8479-7203 ext. 823151899659, YOUHEE2022@yuhs.ac
About this study
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.
- Being tested
- Left atrial reservoir strain
- Keywords
- left atrial reservoir strain, HFA-PEFF, LA strain, Heart failure with preserved ejection fraction (HFpEF)
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial reservoir strainDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| HIgh HFA-PEFF points (≥5) | Not described Receives: Diagnostic Test: Left atrial reservoir strain | |
| Low to intermediate HFA-PEFF points (<5) | Not described Receives: Diagnostic Test: Left atrial reservoir strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minkwan Kim, MD, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638230
- Sponsor's protocol ID
- 9-2022-0101
- Acronym
- RICH-LAST
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37900564
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain
- ClinicalTrials.gov ID
- NCT05638230
- Acronym / sponsor ID
- RICH-LAST / 9-2022-0101
- Keywords
- left atrial reservoir strain, HFA-PEFF, LA strain, Heart failure with preserved ejection fraction (HFpEF)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIgh HFA-PEFF points (≥5) | – | Diagnostic Test: Left atrial reservoir strain |
| Low to intermediate HFA-PEFF points (<5) | – | Diagnostic Test: Left atrial reservoir strain |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Left ventricular ejection fraction <50%
- Supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia)
- Participants who are given pacemaker or ICD implantation procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left atrial reservoir strainLA 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. | Diagnostic test | HIgh HFA-PEFF points (≥5), Low to intermediate HFA-PEFF points (<5) |
Primary outcome
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.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 37900564Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Diastolic and Heart Failure, Preserved Ejection Fraction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minkwan Kim (82-10-4187-0587 ext. 823151898787, minkwan@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.