Serial Biomarker meaSurements and new echocardiographic techniques in chronic Heart Failure patients result in Tailored prediction of prognosis

Serial Biomarker meaSurements and new echocardiographic techniques in chronic Heart Failure patients result in Tailored prediction of prognosis - Bio-SHiFT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44136

Enrollment

400

Registered

2011-03-10

Start date

2011-08-08

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Men and women, aged 18 years or older, capable of understanding and signing informed consent 2. Diagnosis of chronic heart failure, systolic and diastolic, according to the guidelines of the European Society of Cardiology (ESC)

Exclusion criteria

Exclusion criteria: 1. Heart failure secondary to circulatory high output conditions 2. Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion 3. Severe renal failure for which dialysis is needed 4. Coexistent condition with life expectancy * 1 year 5. Unlikely to appear at all scheduled follow-up visits 6. Known moderate or severe liver disease 7. COPD Gold stage IV 8. Congenital heart disease 9. Linguistic barrier

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary endpoints include: - The individual components of the primary endpoint, i.e. cardiovascular death, cardiac transplantation, left ventricular assist device implantation and re-hospitalization for acute or worsened heart failure - Myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) - Cardiovascular disease (includes all of the above) - All-cause mortality	—

Measure

Time frame

Secondary endpoints include: - The individual components of the primary endpoint, i.e. cardiovascular death, cardiac transplantation, left ventricular assist device implantation and re-hospitalization for acute or worsened heart failure - Myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) - Cardiovascular disease (includes all of the above) - All-cause mortality

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Countries

Netherlands

Outcome results