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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014