Heart Failure
Conditions
Keywords
Heart failure, Biomarkers, Echocardiography
Brief summary
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.
Interventions
OTHERObservational study; no intervention.
Sponsors
Medical Center Alkmaar
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac transplantation | maximum follow-up is 2.5 years | — |
| Left ventricular assist device implantation | maximum follow-up is 2.5 years | — |
| Cardiovascular death | 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) | maximum follow-up is 2.5 years | Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components. |
| All-cause mortality | maximum follow-up is 2.5 years | — |
| Re-hospitalization for acute or worsened heart failure | maximum follow-up is 2.5 years | — |
Countries
Netherlands
Outcome results
None listed