NCT03784833

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

6 years

First QC Date

December 20, 2018

Last Update Submit

April 21, 2019

Conditions

Cardiovascular Diseases

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

  • Number of death (all cause)

    Number of death within 2 years of discharge

    2 years of follow-up

Secondary Outcomes (2)

  • Number of rehospitalizations for acute heart failure (HF)

    2 years of follow-up

  • Number of death ( all cause) or readmission for heart failure

    2 years of follow-up

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with heart failure accorrding to Inclusion and exclusion criteria.

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Blood Samples

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • 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

Central Study Contacts

Yuan Wang, Dr

CONTACT

13910161443wangyuan980510@163.com

Bingbing Ke, Dr

CONTACT

155102868571017120710@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

June 1, 2016

Primary Completion

June 1, 2022

Study Completion

June 1, 2024

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

CN(1)