A Registry Study of Biomarkers in Heart Failure

• Conditions: Cardiovascular Diseases

• Registration Number: NCT03784833
• Lead Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-21
• Last Update Posted: 2019-04-23
• Primary Completion: 2022-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of death (all cause)	2 years of follow-up	Number of death within 2 years of discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China