NCT01851538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

9.3 years

First QC Date

May 7, 2013

Last Update Submit

February 5, 2021

Conditions

Heart Failure

Keywords

Heart failureBiomarkersEchocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Cardiovascular death

    maximum follow-up is 2.5 years

  • Cardiac transplantation

    maximum follow-up is 2.5 years

  • Left ventricular assist device implantation

    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

  • +1 more secondary outcomes

Study Arms (1)

Chronic heart failure patients visiting the outpatient clinic

Other: Observational study; no intervention.

Interventions

Observational study; no intervention.OTHER
Chronic heart failure patients visiting the outpatient clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic heart failure patients visiting the outpatient clinic.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Center Alkmaar

Alkmaar, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (5)

  • de Bakker M, Petersen TB, Rueten-Budde AJ, Akkerhuis KM, Umans VA, Brugts JJ, Germans T, Reinders MJT, Katsikis PD, van der Spek PJ, Ostroff R, She R, Lanfear D, Asselbergs FW, Boersma E, Rizopoulos D, Kardys I. Machine learning-based biomarker profile derived from 4210 serially measured proteins predicts clinical outcome of patients with heart failure. Eur Heart J Digit Health. 2023 Oct 4;4(6):444-454. doi: 10.1093/ehjdh/ztad056. eCollection 2023 Dec.

    PMID: 38045440DERIVED

  • Petersen TB, de Bakker M, Asselbergs FW, Harakalova M, Akkerhuis KM, Brugts JJ, van Ramshorst J, Lumbers RT, Ostroff RM, Katsikis PD, van der Spek PJ, Umans VA, Boersma E, Rizopoulos D, Kardys I. HFrEF subphenotypes based on 4210 repeatedly measured circulating proteins are driven by different biological mechanisms. EBioMedicine. 2023 Jul;93:104655. doi: 10.1016/j.ebiom.2023.104655. Epub 2023 Jun 14.

    PMID: 37327673DERIVED

  • Klimczak-Tomaniak D, de Bakker M, Bouwens E, Akkerhuis KM, Baart S, Rizopoulos D, Mouthaan H, van Ramshorst J, Germans T, Constantinescu A, Manintveld O, Umans V, Boersma E, Kardys I. Dynamic personalized risk prediction in chronic heart failure patients: a longitudinal, clinical investigation of 92 biomarkers (Bio-SHiFT study). Sci Rep. 2022 Feb 18;12(1):2795. doi: 10.1038/s41598-022-06698-3.

    PMID: 35181700DERIVED

  • Bouwens E, Schuurman AS, Akkerhuis KM, Manintveld OC, Caliskan K, van Ramshorst J, Germans T, Umans VA, Boersma E, Kardys I. Associations of serially measured PCSK9, LDLR and MPO with clinical outcomes in heart failure. Biomark Med. 2021 Mar;15(4):247-255. doi: 10.2217/bmm-2020-0585. Epub 2021 Feb 16.

    PMID: 33590771DERIVED

  • Bouwens E, Brankovic M, Mouthaan H, Baart S, Rizopoulos D, van Boven N, Caliskan K, Manintveld O, Germans T, van Ramshorst J, Umans V, Akkerhuis KM, Kardys I. Temporal Patterns of 14 Blood Biomarker candidates of Cardiac Remodeling in Relation to Prognosis of Patients With Chronic Heart Failure-The Bio- SH i FT Study. J Am Heart Assoc. 2019 Feb 19;8(4):e009555. doi: 10.1161/JAHA.118.009555.

    PMID: 30760105DERIVED

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).

MeSH Terms

Conditions

Heart Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Eric Boersma, MSc, PhD

    Erasmus Medical Center

    STUDY CHAIR

  • Isabella Kardys, MD, PhD

    Erasmus Medical Center

    STUDY DIRECTOR

  • Victor Umans, MD, PhD

    Medical Center Alkmaar

    PRINCIPAL INVESTIGATOR

  • Martijn Akkerhuis, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 10, 2013

Study Start

August 1, 2011

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

NL(2)