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

Heart Failure Clinical Trial

— Bio-SHiFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851538
• Other study ID #: MEC-2011-029
• Status: Completed
• Start date: August 2011
• Est. completion date: November 2020

Study information

• Verified date: February 2021
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Observational study; no intervention.

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar
Netherlands	Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death		maximum follow-up is 2.5 years
Secondary	Cardiac transplantation		maximum follow-up is 2.5 years
Secondary	Left ventricular assist device implantation		maximum follow-up is 2.5 years
Secondary	Re-hospitalization for acute or worsened heart failure		maximum follow-up is 2.5 years
Secondary	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
Secondary	All-cause mortality		maximum follow-up is 2.5 years