Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure

Tongji University

Status: Unknown

Conditions: Heart Failure

Treatments: Diagnostic Test: Patients with heart failure

Study type: Observational

Funder types: Other

Identifiers

NCT03727828

DRAGON-HF

Details and patient eligibility

About

The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.

Full description

Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age > 18 years of age
2. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
3. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion criteria

1. Life expectancy <1 year due to causes other than HF such as advanced cancer
2. Cardiac transplantation or revascularization indicated or expected within 6 months
3. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
4. Subject unable or unwilling to provide written informed consent
5. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
6. Progressive neurological disease
7. Pregnancy

Trial design

3,000 participants in 2 patient groups

Patients with heart failure

Description:

Patients with heart failure (HF) who are followed in the hospital or clinic setting, with optimization of medical therapy and blood collection.

Treatment:

Diagnostic Test: Patients with heart failure

healthy control