The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients

Study Overview
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Brief Summary
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The Bio-SHiFT study aims to investigate whether disease progression in individual patients with chronic heart failure (CHF) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. Secondary objectives of the study include comparison of 2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic measurements to clinical outcome. Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.

Official Title
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Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Observational study; no intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, aged 18 years or older, capable of understanding and signing informed consent Diagnosis of chronic heart failure (with diminished ejection fraction or with normal ejection fraction), according to the guidelines of the European Society of Cardiology (ESC) Exclusion Criteria: Heart failure secondary to circulatory high output conditions Scheduled for surgery or intervention for both coronary and non-coronary indication Severe renal failure for which dialysis is needed Known moderate or severe liver disease Chronic Obstructive Pulmonary Disease (COPD) Gold stage IV Congenital heart disease Coexistent condition with life expectancy ≤ 1 year Unlikely to appear at all scheduled follow-up visits Linguistic barrier

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic heart failure patients visiting the outpatient clinic<br> | Other: Observational study; no intervention.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure. |  | maximum follow-up is 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | maximum follow-up is 2.5 years | 
| Cardiac transplantation |  | maximum follow-up is 2.5 years | 
| Left ventricular assist device implantation |  | maximum follow-up is 2.5 years | 
| Re-hospitalization for acute or worsened heart failure |  | maximum follow-up is 2.5 years | 
| Cardiovascular disease: myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) | Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components. | maximum follow-up is 2.5 years | 
| All-cause mortality |  | maximum follow-up is 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Biomarkers, Echocardiography