A Registry Study of Biomarkers in Heart Failure

Cardiovascular Diseases Clinical Trial

— BIOMS-HF  

Official title:

A Registry Study of Biomarkers in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03784833
• Other study ID #: BIOMS-HF
• Status: Recruiting
• Start date: June 2016
• Est. completion date: June 2024

Study information

• Verified date: April 2019
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yuan Wang, Dr
• Phone: 13910161443
• Email: wangyuan980510[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2024
• Est. primary completion date: June 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases	Beijing Luhe Hospital, China-Japan Friendship Hospital, Second Affiliated Hospital of Wenzhou Medical University, Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of death (all cause)	Number of death within 2 years of discharge	2 years of follow-up
Secondary	Number of rehospitalizations for acute heart failure (HF)	Number of heart failure related hospitalization within 2 years of discharge	2 years of follow-up
Secondary	Number of death ( all cause) or readmission for heart failure	Number of Death or heart failure related hospitalization within 2 years of discharge	2 years of follow-up