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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Patients with heart failure


Participation Criteria
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Eligibility Criteria
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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 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with heart failure<br>Patients with heart failure (HF) who are followed in the hospital or clinic setting, with optimization of medical therapy and blood collection. | Diagnostic Test: Patients with heart failure<br>* Participants will have serial blood collection on medical therapy for heart failure<br>|
| healthy control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cardiaovascular death after 5-year follow up | The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers | 5 years | 
| Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm | New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure | 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. | 1 year | 
| Change From Baseline in left ventricular ejection fraction | Assess the change in left ventricular ejection fraction at the end of 5-year follow up. | 5 years | 
| Change From Baseline in left ventricular end-systolic volume | Assess the change in left ventricular end-systolic volume at the end of 5-year follow up. | 5 years |