Registry for Longitudinal Mortality and Therapy in Patien... | NCT04062500

Studies
Registry for Longitudinal Mortality and Therapy in Patients With Heart Failure

NCT04062500

Sponsor

Shanghai 10th People's Hospital

Status

Recruiting

Last Update Posted

Aug 17, 2020Actual

Enrollment

10,500Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Mortality and Rehospitalization rate

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 9, 2019

First Submission Date that Met QC Criteria

Aug 19, 2019

First Posted Date

Aug 20, 2019Actual

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

Aug 14, 2020

Last Update Posted Date

Aug 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ya-Wei Xu, MD, pHD, Director of Cardiovascular Department, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Name	Class
First Affiliated Hospital, Sun Yat-Sen University	OTHER
Nanfang Hospital, Southern Medical University	OTHER
Beijing Chao Yang Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from hospitals across China.

Detailed Description

Registry for Longitudinal mortality and therapy in patients with Heart Failure is a large, multicenter, prospective, open-label registry of the management of patients treated in the hospital for acute heart failure in China. The objective of this study is to investigate the clinical features and prognosis of patients with heart failure, and discover the characteristics of high-risk heart failure patients, and elucidate critical factors which predict the development and outcomes of symptomatic heart failure patients.

To elucidate the clinical characteristics and prognostic risks of patients with heart failure.
To study the characteristics of high-risk heart failure patients and predict the key factors for the development of symptomatic heart failure patients.
To elucidate the compliance of patients with heart failure and the incidence of adverse drug effects.
To investigate the effect of self-management on outcomes in patients with heart failure.
To elucidate critical factors associated with the development and outcomes of heart failure.
To investigate hospitalization expenses for heart failure.

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

Enrollment

10,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with heart failure		patients treated in the hospital for acute heart failure in China	Other: Mortality and Rehospitalization rate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mortality and Rehospitalization rate	Other	Mortality and Re-hospitalization of acute decompensated heart failure	Patients with heart failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality of acute decompensated heart failure	In-hospital and Annual mortality	10 years
Re-hospitalization rate	Re-hospitalization of acute decompensated heart failure	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 1. 18 years and older. 2. Meet the diagnostic criteria of China 2018 or JACC/AHA 2017 or ESC 2016 heart failure guidelines.

3. Agree to be tested and sign an informed consent certificate.

Exclusion Criteria:

1. Age<18 years old. 2. Patients who refused to participate. 3. Patients may have a life expectancy of less than 1 years due to non- heart failure clinical conditions.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with heart failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dachun Xu, PhD	Contact	18917684045	+86	xdc77@tongji.edu.cn

Overall Officials

Name	Affiliation	Role
Dachun Xu, PhD	Shanghai Tenthth People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Tenth People's Hospital, Tongji University	Recruiting	Shanghai	Shanghai Municipality	200072	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32973950	Derived	Su Y, Ma M, Zhang H, Pan X, Zhang X, Zhang F, Lv Y, Yan C. Prognostic value of serum hyponatremia for outcomes in patients with heart failure with preserved ejection fraction: An observational cohort study. Exp Ther Med. 2020 Nov;20(5):101. doi: 10.3892/etm.2020.9231. Epub 2020 Sep 17.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D014798	Vital Statistics
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques