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

This study is currently recruiting participants.
Verified February 2014 by Erasmus Medical Center
Sponsor:
Collaborator:
Medical Center Alkmaar
Information provided by (Responsible Party):
Eric Boersma, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01851538
First received: May 7, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Heart Failure
Other: Observational study; no intervention.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular death [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]
  • Cardiac transplantation [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]
  • Left ventricular assist device implantation [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]
  • Re-hospitalization for acute or worsened heart failure [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components.

  • All-cause mortality [ Time Frame: maximum follow-up is 2.5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood (EDTA plasma, citrate plasma, serum, DNA) and urine samples are taken at the day of inclusion and at follow-up visits, which will be performed every 3 months, until the end of the scheduled follow-up, or until the patient dies. The maximum total number of samples per patient is 11 (in patients with 30 months follow-up).


Estimated Enrollment: 400
Study Start Date: August 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic heart failure patients visiting the outpatient clinic Other: Observational study; no intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic heart failure patients visiting the outpatient clinic.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851538

Contacts
Contact: Isabella Kardys, MD, PhD +31107035048 i.kardys@erasmusmc.nl
Contact: Eric Boersma, MSc, PhD +31107032307 h.boersma@erasmusmc.nl

Locations
Netherlands
Medical Center Alkmaar Recruiting
Alkmaar, Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Medical Center Alkmaar
Investigators
Study Chair: Eric Boersma, MSc, PhD Erasmus MC
Study Director: Isabella Kardys, MD, PhD Erasmus MC
Principal Investigator: Victor Umans, MD, PhD Medical Center Alkmaar
Principal Investigator: Martijn Akkerhuis, MD, PhD Erasmus MC
  More Information

No publications provided

Responsible Party: Eric Boersma, Prof.dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01851538     History of Changes
Other Study ID Numbers: MEC-2011-029
Study First Received: May 7, 2013
Last Updated: February 18, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Heart failure
Biomarkers
Echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014