A Registry Study of Biomarkers in Heart Failure | NCT03784833

Studies
A Registry Study of Biomarkers in Heart Failure

NCT03784833

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status

Unknown status

Last Update Posted

Apr 23, 2019Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Dec 20, 2018

First Submission Date that Met QC Criteria

Dec 20, 2018

First Posted Date

Dec 24, 2018Actual

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

Apr 21, 2019

Last Update Posted Date

Apr 23, 2019Actual

Name	Class
Tianjin Medical University Second Hospital	OTHER
Second Affiliated Hospital of Wenzhou Medical University	OTHER
Beijing Luhe Hospital	OTHER

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

The registry study aims to discover the prognostic value of bio-markers in heart failure

Detailed Description

The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

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

Retention

Not provided

Description

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of death (all cause)	Number of death within 2 years of discharge	2 years of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Number of rehospitalizations for acute heart failure (HF)	Number of heart failure related hospitalization within 2 years of discharge	2 years of follow-up
Number of death ( all cause) or readmission for heart failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than or equal to 18 years at the time of admission to the hospital
With symptoms of new-onset or worsening heart failure
Received or is eligible to receive a principal hospital discharge diagnosis of HF
With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;

Exclusion Criteria:

Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) <35 pg/mL or <125 pg/ml, respectively
Current known inability to follow instructions or comply with follow-up procedures.
Eligible patients without informed consent form

Accepts Healthy Volunteers

Not provided

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

Patients with heart failure accorrding to Inclusion and exclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuan Wang, Dr	Contact	13910161443		wangyuan980510@163.com
Bingbing Ke, Dr	Contact	15510286857		1017120710@qq.com

Overall Officials

Name	Affiliation	Role
Jie Du, Dr	The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital	Recruiting	Beijing	Beijing Municipality	100029	China