Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Erasmus Medical Center
- Enrollment
- 398
- Locations
- 2
- Primary Endpoint
- The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eric Boersma
Prof.dr.
Erasmus Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.
Time Frame: maximum follow-up is 2.5 years
Secondary Outcomes
- Cardiovascular death(maximum follow-up is 2.5 years)
- Left ventricular assist device implantation(maximum follow-up is 2.5 years)
- Cardiac transplantation(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)(maximum follow-up is 2.5 years)
- All-cause mortality(maximum follow-up is 2.5 years)