Clinical trial NCT01851538: The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients
Official title: Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Biomarkers
Echocardiography
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Center Alkmaar
First posted: 2013-05-10
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic heart failure patients visiting the outpatient clinic.

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.


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

Primary outcomes:
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.
timeFrame: maximum follow-up is 2.5 years
Secondary outcomes:
measure: Cardiovascular death
timeFrame: maximum follow-up is 2.5 years
measure: Cardiac transplantation
timeFrame: maximum follow-up is 2.5 years
measure: Left ventricular assist device implantation
timeFrame: maximum follow-up is 2.5 years
measure: Re-hospitalization for acute or worsened heart failure
timeFrame: maximum follow-up is 2.5 years
measure: Cardiovascular disease: myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)
timeFrame: maximum follow-up is 2.5 years
measure: All-cause mortality
timeFrame: maximum follow-up is 2.5 years
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Eric Boersma, MSc, PhD
role: STUDY_CHAIR
affiliation: Erasmus Medical Center
name: Isabella Kardys, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical Center Alkmaar
name: Victor Umans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Martijn Akkerhuis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.