Since the ELAN-HF score has only been externally validated in one cohort, the primary objective of this study is to perform an external validation of the ELAN-HF score in a cohort of patients admitted with ADHF at the Catharina Hospital. A second…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the ELAN-HF score, biomarker levels and
clinical data that is collected during study inclusion. The main study
endpoints are all-cause mortality and a composite of all-cause mortality and/or
first readmission for cardiovascular reasons within 6 months after discharge.
Secondary outcome
Assess the associations between biomarker levels in patients admitted with ADHF
and:
- cause-specific mortality 6 months after discharge.
- recurrent hospitalizations.
- QoL outcomes early after discharge and 6 months after discharge.
Develop a prognostic model that predicts QoL outcomes for patients that are
admitted with acutely decompensated heart failure, based on serial measurements
of a panel of biomarkers and clinical variables contained in electronic health
records.
Assess prognostic value of features extracted from continuous PPG and
accelerometer data from the Elan device in patients that are discharged after
they have been treated for ADHF. Assess agreement between a Hemodynamics model
and the assessment of the degree of decompensation by the cardiologist.
Background summary
Heart Failure (HF) accounts for 1-3% of all US and European hospital
admissions. Patients admitted with acute decompensated HF (ADHF) have poor
short- and long-term prognosis, after discharge * 20% of patients are
readmitted within 30 days and up to 50% by 6 months. A reduction in HF
readmissions simultaneously improves the quality of care and reduces costs. To
reduce HF readmission rates a comprehensive characterization of predictors of
readmission in patients with HF is imperative. Multivariable risk scores can
predict risk for adverse events such as readmission or mortality in patients
admitted with ADHF. High risk patients can be targeted for intervention or
indicate incomplete treatment in hospital. The ELAN-HF score is a novel, simple
and yet robust discharge risk score developed by Salah et. al that incorporates
natriuretic peptide levels in addition to known risk markers to predict adverse
events. Next to natriuretic peptide levels, other biomarkers have emerged that
allow prognostication of patients admitted with ADHF. Recent studies have shown
that combining multiple biomarkers in a multimarker panel, substantially
improves prediction of adverse events beyond current metrics.
Study objective
Since the ELAN-HF score has only been externally validated in one cohort, the
primary objective of this study is to perform an external validation of the
ELAN-HF score in a cohort of patients admitted with ADHF at the Catharina
Hospital. A second primary objective is to serially measure a multimarker panel
in this cohort and combine these measurements with clinical data from multiple
sources (e.g. prescribed medication, medical history, physiological
measurements etc.) to capture the heterogeneous nature of HF in a novel
discharge risk score.
Study design
This study is a prospective, non-randomized, observational, single-center
cohort study.
Study burden and risks
There are minimal risks associated with participation in this study, most
measurements performed during this study are part of routine care. The
additional burden is presented in the form of extra vials of blood that need to
be withdrawn on admission, discharge and one week of discharge, attachment of a
watch that registers PPG signals (in a subgroup of patients), and three moments
in time where a questionnaire has to be filled in.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Undergo treatment for ADHF.
Aged 18 or above and mentally competent.
Capable of understanding the Dutch language.
Exclusion criteria
Patients where follow-up is not possible (e.g. in-hospital mortality or follow-up not taking place at the Catharina Hospital).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65323.100.18 |
OMON | NL-OMON27799 |