Heart Failure With Improved Ejection Fraction and Deep Le... | NCT06070506

Studies
Heart Failure With Improved Ejection Fraction and Deep Learning

NCT06070506

Sponsor

Yihui Kong

Status

Completed

Last Update Posted

Oct 11, 2023Actual

Enrollment

422Actual

Phase

Not provided

Conditions

Heart Failure
Diagnosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

May 20, 2023Actual

First Submitted Date

Aug 30, 2023

First Submission Date that Met QC Criteria

Sep 30, 2023

First Posted Date

Oct 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2023

Last Update Posted Date

Oct 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

422Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HFrEF group		Heart failure patients with LVEF persistently ≤40%.
HFimpEF group		Heart failure patients with previous LVEF ≤40% and a follow-up LVEF of more than 40%.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of left ventricular ejection fraction	left ventricular ejection fraction value in millimeters	3 months

Secondary Outcomes

Measure	Description	Time Frame
change of clinical predictor of EF improvement	weight in kilograms, height in meters(weight and height will be combined to report BMI in kg/m^2)	3 months
the independent clinical predictor of HFimpEF

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years.
The diagnostic criteria of HF follows the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, having symptoms of dyspnea, fatigue or decreased activity tolerance, having signs of fluid retention (such as pulmonary congestion and peripheral edema), having echocardiogram abnormalities in cardiac structure and/or function, showing elevated natriuretic peptide levels (BNP>35 ng/L or/and N-terminal pro-BNP >125 ng/L).
Have reviewing echocardiography after discharge.

Exclusion Criteria:

Patients with hypertrophic, restrictive, or invasive cardiomyopathy and congenital or rheumatic heart disease.
Patients with heart transplantation during follow-up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The participants in the study are HF patients hospitalized in the Department of Cardiology of the First Affiliated Hospital of Harbin Medical University who had no less than two echocardiograms at baseline and during the follow-up period, between January 2014 to December 2022.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Yihui Kong		Harbin	Heilongjiang	150000	China

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D004194	Disease

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided