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

May 7, 2013
February 18, 2014
August 2011
December 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01851538 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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).

Non-Probability Sample

Chronic heart failure patients visiting the outpatient clinic.

Heart Failure
Other: Observational study; no intervention.
Chronic heart failure patients visiting the outpatient clinic
Intervention: Other: Observational study; no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Isabella Kardys, MD, PhD +31107035048 i.kardys@erasmusmc.nl
Contact: Eric Boersma, MSc, PhD +31107032307 h.boersma@erasmusmc.nl
Netherlands
 
NCT01851538
MEC-2011-029
Not Provided
Eric Boersma, Erasmus Medical Center
Erasmus Medical Center
Medical Center Alkmaar
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
Erasmus Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP