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

April 11, 2023 updated by: Goo-Yeong Cho, Seoul National University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients hospitalized for acute heart failure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute heart failure
Patients hospitalized for acute heart failure and underwent echocardiography with speckle-tracking imaging
Diagnostic test: Echocardiography with speckle-tracking imaging
  1. Measurement of left ventricular ejection fraction and global longitudinal strain
  2. Measurement of left atrial reservoir strain (peak atrial longitudinal strain)
  3. Measurement of right ventricular global longitudinal strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: up to 5 years
Death from any cause
up to 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital
Chungnam National University Hospital

Investigators

  • Principal Investigator: Goo-Yeong Cho, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

September 5, 2017

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1702/384-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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