Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Shanghai 10th People's Hospital
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Number of participants with cardiaovascular death after 5-year follow up
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Ya-Wei Xu
Professor
Shanghai 10th People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years of age
- •Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- •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
- •Life expectancy \<1 year due to causes other than HF such as advanced cancer
- •Cardiac transplantation or revascularization indicated or expected within 6 months
- •Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 L (when diagnosed as standard of care)
- •Subject unable or unwilling to provide written informed consent
- •Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
- •Progressive neurological disease
Outcomes
Primary Outcomes
Number of participants with cardiaovascular death after 5-year follow up
Time Frame: 5 years
The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
Time Frame: 5 years
New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.
Secondary Outcomes
- Change From Baseline in left ventricular ejection fraction(5 years)
- Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure(1 year)
- Change From Baseline in left ventricular end-systolic volume(5 years)