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| Name | Class |
|---|---|
| Medical Center Alkmaar | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic heart failure patients visiting the outpatient clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study; no intervention. | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | maximum follow-up is 2.5 years | |
| Cardiac transplantation | maximum follow-up is 2.5 years | |
| Left ventricular assist device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic heart failure patients visiting the outpatient clinic.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Alkmaar | Alkmaar | Netherlands | ||||
| Erasmus MC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38408202 | Derived | 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. | |
| 38045440 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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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).
| 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) | Cardiovascular disease, comprising all events specified above, will be examined, as well as all individual components. | maximum follow-up is 2.5 years |
| All-cause mortality | maximum follow-up is 2.5 years |
| Rotterdam |
| Netherlands |
| Derived |
| 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. |
| 37327673 | Derived | 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. |
| 35181700 | Derived | 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. |
| 33590771 | Derived | 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. |
| 30760105 | Derived | 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. |