Prognostic Factors of Patients With ADHF | NCT04390919

Studies
Prognostic Factors of Patients With ADHF

NCT04390919

Sponsor

Chongqing Medical University

Status

Completed

Last Update Posted

May 18, 2020Actual

Enrollment

362Actual

Phase

Not provided

Conditions

Acute Decompensated Heart Failure

Interventions

elevated monocyte count

Countries

Not provided

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

May 2020

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

Aug 2, 2011Actual

Primary Completion Date

Feb 16, 2015Actual

Completion Date

Feb 16, 2015Actual

First Submitted Date

May 4, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 18, 2020Actual

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

May 13, 2020

Last Update Posted Date

May 18, 2020Actual

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

Description Module

Brief Summary

To explore the prognostic indicators for patients with ADHF

Detailed Description

According to ESC Guidelines for the diagnosis of acute heart failure 2008, patients with ADHF were diagnosed, and their medical history, laboratory examination and treatment plan were retrospectively analyzed, and the patients were followed up for 1 year. The 1-year outcomes of patients were analyzed to explore the prognostic indicators for patients with ADHF

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

362Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high group		high group: monocyte count≥0.445×10*9 cells/L	Other: elevated monocyte count
low group		low group: monocyte count<0.445×10*9 cells/L;

Interventions

Name	Type	Description	Arm Group Labels	Other Names
elevated monocyte count	Other	The monocyte count at admission was higher than 0.445×10*9 cells/L	high group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause death	The primary end point was one-year all-cause death	1 year

Secondary Outcomes

Measure	Description	Time Frame
HF-related rehospitalization	the secondary end point was one-year HF-related rehospitalization.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ADHF diagnosed according to ESC Guidelines for the diagnosis of acute heart failure 2008

Exclusion Criteria:

disorders of the hematopoietic system, history of cancer and/or previous treatment with chemotherapy, the infection caused by various pathogens, chronic inflammatory conditions, glucocorticoid therapy and/or histories of glucocorticoid use 3 months before the admission and acute myocardial infarction or coronary revascularization within the past 6 months. Also, patients who did not have a differential WBC count or who were lost to follow-up were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

94 Years

Standard Ages

AdultOlder Adult

Study Population

ADHF patient diagnosed in the department of cardiovascular medicine in the first affiliated hospital of chongqing medical university

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided