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Heart FailureBio-SHiFTNCT01851538

The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients

An observational study of Heart Failure, run by Erasmus Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
398 participants
Where
2 sitesNetherlands
Study dates
Aug 2011to Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chronic heart failure patients visiting the outpatient clinic.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • Coexistent condition with life expectancy ≤ 1 year
  • Unlikely to appear at all scheduled follow-up visits
  • Linguistic barrier

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Medical Center Alkmaar

    Alkmaar

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
Observational study; no intervention.
Keywords
Heart failure, Biomarkers, Echocardiography
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational study; no intervention.Other

Study groups in NCT01851538
Study groupRoleWhat they receive
Chronic heart failure patients visiting the outpatient clinicNot described
Receives: Other: Observational study; no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: maximum follow-up is 2.5 years

Secondary outcomes (6)

  1. Cardiovascular death

    Measured: maximum follow-up is 2.5 years

  2. Cardiac transplantation

    Measured: maximum follow-up is 2.5 years

  3. Left ventricular assist device implantation

    Measured: maximum follow-up is 2.5 years

  4. Re-hospitalization for acute or worsened heart failure

    Measured: maximum follow-up is 2.5 years

  5. Cardiovascular disease: myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)

    Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components.

    Measured: maximum follow-up is 2.5 years

  6. All-cause mortality

    Measured: maximum follow-up is 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2020
  4. Study completionNov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01851538
Sponsor's protocol ID
MEC-2011-029
Acronym
Bio-SHiFT
Status last verified
Feb 2021
First submitted
7 May 2013
Last updated
8 Feb 2021
Results posted
No

Publications

  • Klimczak-Tomaniak D, Andrzejczyk K, Abou Kamar S, Baart S, van Boven N, Akkerhuis KM, Constantinescu A, Caliskan K, Simsek S, Germanse T, van Ramshorst J, Brugts J, Kuch M, Umans V, Boersma E, Kardys I. Temporal evolution of liver function parameters predicts clinical outcome in chronic heart failure patients (Bio-SHiFT study). Cardiol J. 2024;31(3):409-417. doi: 10.5603/cj.95174. Epub 2024 Feb 26.

    PubMed 38408202

  • 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.

    PubMed 38045440

  • 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.

    PubMed 37327673

  • 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.

    PubMed 35181700

  • 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.

    PubMed 33590771

  • 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.

    PubMed 30760105

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Erasmus Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01851538, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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