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

Completed

• Conditions: Heart Failure
• Interventions: Other: Observational study; no intervention.

• Registration Number: NCT01851538
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-10
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic heart failure patients visiting the outpatient clinic	Observational study; no intervention.	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality	maximum follow-up is 2.5 years
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	Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components.

Trial Locations

Locations (2)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Medical Center Alkmaar; 🇳🇱 Alkmaar, Netherlands