Heart Failure
Conditions
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.
Interventions
DIAGNOSTIC_TESTPatients with heart failure
Participants will have serial blood collection on medical therapy for heart failure
Sponsors
Tongji Hospital
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Chinese Academy of Medical Sciences, Fuwai Hospital
Yangpu Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Huashan Hospital Baoshan Branch
Shanghai Zhongye Hospital
Shanghai BaoshanLuodianHospital
Shanghai Shibei Hospital
Nantong Sixth People's Hospital
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with cardiaovascular death after 5-year follow up | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure | 1 year | Compare the sensitivity and specificity of new biomarker with NT-ProBNP to assess the accuracy of diagnostic value in discriminating heart failure from non-heart failure participants. |
| Change From Baseline in left ventricular ejection fraction | 5 years | Assess the change in left ventricular ejection fraction at the end of 5-year follow up. |
| Change From Baseline in left ventricular end-systolic volume | 5 years | Assess the change in left ventricular end-systolic volume at the end of 5-year follow up. |
Countries
China
Contacts
Primary ContactDachun Xu, Ph.D
Backup ContactYuxi Sun, Ph.D
Outcome results
None listed