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NCT03513653 Clinical Trial

Strain for Risk Assessment and Therapeutic Strategies in Patients With Acute Heart Failure (STRATS-AHF) Registry

Heart Failure Clinical Trial

— STRATS-AHF  

Official title:
Strain for Risk Assessment and Therapeutic Strategies in Patients With Acute Heart Failure (STRATS-AHF) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03513653
Other study ID # B-1702/384-111
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2023

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

STRATS-AHF (STrain for Risk Assessment and Therapeutic Strategies in patients with Acute Heart Failure) registry enrolled 4,312 patients hospitalized for acute HF from 3 tertiary university hospitals (Seoul National University Bundang Hospital, Seoul National University Hospital, and Chungnam National University Hospital) from January 2009 through December 2016.

Description:

Patients with signs or symptoms of heart failure and either lung congestion, or objective findings of left ventricular (LV) systolic dysfunction or structural heart disease, were eligible for the study. Echocardiography was performed and both LV ejection fraction (LVEF) and LV global longitudinal strain (LV-GLS), right ventricular GLS (RV-GLS) were measured.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4312
Est. completion date December 31, 2023
Est. primary completion date September 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with signs or symptoms of HF and either lung congestion, or objective findings of LV systolic dysfunction or structural heart disease Exclusion Criteria: - Patients who presented with acute coronary syndrome

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Echocardiography with speckle-tracking imaging
Measurement of left ventricular ejection fraction and global longitudinal strain Measurement of left atrial reservoir strain (peak atrial longitudinal strain) Measurement of right ventricular global longitudinal strain

Locations
Country Name City State
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (3)
Lead Sponsor Collaborator
Seoul National University Hospital Chungnam National University Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Hwang IC, Cho GY, Choi HM, Yoon YE, Park JJ, Park JB, Park JH, Lee SP, Kim HK, Kim YJ, Sohn DW. Derivation and validation of a mortality risk prediction model using global longitudinal strain in patients with acute heart failure. Eur Heart J Cardiovasc Imaging. 2020 Dec 1;21(12):1412-1420. doi: 10.1093/ehjci/jez300. — View Citation

Park CS, Park JB, Park JJ, Park JH, Cho GY. Impact of sex and myocardial function on association of obesity with mortality in Asian patients with acute heart failure: a retrospective analysis from the STRATS-AHF registry. BMJ Open. 2020 Feb 10;10(2):e031608. doi: 10.1136/bmjopen-2019-031608. — View Citation

Park JH, Hwang IC, Park JJ, Park JB, Cho GY. Prognostic power of left atrial strain in patients with acute heart failure. Eur Heart J Cardiovasc Imaging. 2021 Jan 22;22(2):210-219. doi: 10.1093/ehjci/jeaa013. — View Citation

Park JH, Park JJ, Park JB, Cho GY. Prognostic Value of Biventricular Strain in Risk Stratifying in Patients With Acute Heart Failure. J Am Heart Assoc. 2018 Oct 2;7(19):e009331. doi: 10.1161/JAHA.118.009331. — View Citation

Park JJ, Choi HM, Hwang IC, Park JB, Park JH, Cho GY. Myocardial Strain for Identification of beta-Blocker Responders in Heart Failure with Preserved Ejection Fraction. J Am Soc Echocardiogr. 2019 Nov;32(11):1462-1469.e8. doi: 10.1016/j.echo.2019.06.017. Epub 2019 Sep 17. — View Citation

Park JJ, Mebazaa A, Hwang IC, Park JB, Park JH, Cho GY. Phenotyping Heart Failure According to the Longitudinal Ejection Fraction Change: Myocardial Strain, Predictors, and Outcomes. J Am Heart Assoc. 2020 Jun 16;9(12):e015009. doi: 10.1161/JAHA.119.015009. Epub 2020 Jun 10. — View Citation

Park JJ, Park JB, Park JH, Cho GY. Global Longitudinal Strain to Predict Mortality in Patients With Acute Heart Failure. J Am Coll Cardiol. 2018 May 8;71(18):1947-1957. doi: 10.1016/j.jacc.2018.02.064. — View Citation

Park JJ, Park JH, Hwang IC, Park JB, Cho GY, Marwick TH. Left Atrial Strain as a Predictor of New-Onset Atrial Fibrillation in Patients With Heart Failure. JACC Cardiovasc Imaging. 2020 Oct;13(10):2071-2081. doi: 10.1016/j.jcmg.2020.04.031. Epub 2020 Jul 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality Death from any cause up to 5 years
Secondary Hospitalization for heart failure Any hospitalization for acute heart failure after the index hospitalization up to 5 years
Secondary Composite of all-cause mortality and hospitalization for heart failure Death from any cause or any hospitalization for acute heart failure after the index hospitalization up to 5 years
Secondary Ischemic stroke Ischemic stroke (an episode of neurological dysfunction caused by embolism) after the index hospitalization up to 5 years
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