The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients (Bio-SHiFT)

Erasmus University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Observational study; no intervention.

Study type: Observational

Funder types: Other

Identifiers

NCT01851538

MEC-2011-029

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

398 participants in 1 patient group

Chronic heart failure patients visiting the outpatient clinic

Treatment:

Other: Observational study; no intervention.