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

February 5, 2021 updated by: Eric Boersma, Erasmus Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alkmaar, Netherlands
        • Medical Center Alkmaar
      • Rotterdam, Netherlands
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic heart failure patients visiting the outpatient clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic heart failure patients visiting the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
maximum follow-up is 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: maximum follow-up is 2.5 years
maximum follow-up is 2.5 years
Cardiac transplantation
Time Frame: maximum follow-up is 2.5 years
maximum follow-up is 2.5 years
Left ventricular assist device implantation
Time Frame: maximum follow-up is 2.5 years
maximum follow-up is 2.5 years
Re-hospitalization for acute or worsened heart failure
Time Frame: maximum follow-up is 2.5 years
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)
Time Frame: maximum follow-up is 2.5 years
Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components.
maximum follow-up is 2.5 years
All-cause mortality
Time Frame: maximum follow-up is 2.5 years
maximum follow-up is 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Eric Boersma, MSc, PhD, Erasmus Medical Center
  • Study Director: Isabella Kardys, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Victor Umans, MD, PhD, Medical Center Alkmaar
  • Principal Investigator: Martijn Akkerhuis, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2011-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Observational study; no intervention.

3
Subscribe