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

NCT ID: NCT01851538

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 398 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2020-11-30

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic heart failure patients visiting the outpatient clinic

Observational study; no intervention.

Intervention Type: OTHER

Interventions

Observational study; no intervention.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Boersma

Prof.dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Boersma, MSc, PhD

Role: STUDY_CHAIR

Erasmus Medical Center

Isabella Kardys, MD, PhD

Role: STUDY_DIRECTOR

Erasmus Medical Center

Victor Umans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Martijn Akkerhuis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Medical Center Alkmaar

Alkmaar, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 38045440 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37327673 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35181700 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33590771 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30760105 (View on PubMed)

Other Identifiers

MEC-2011-029

Identifier Type: -

Identifier Source: org_study_id