The primary objective of this study is to develop an objective, clinical relevant classification model of disease severity for patients with HF based on an extensive, complete dataset of patients with HF.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are echocardiographic structural and functional measures,
blood marker levels, QOL scores, 6MWT (and when measured (spiro-)ergometry)
performance scores, (24 hour) ECG-derived variables, 24 hour blood pressure
measurements, and PPG and accelerometer data of patients with HF.
The main study endpoint is an objective classification model for HF patients
where the model output is represented as a scale of HF disease severity
reflected by clinically relevant, objective measures. The study endpoint for
the participant is the composite endpoint of all-cause mortality, heart
transplantation or Left Ventricular Assist Device (LVAD) implantation.
Secondary outcome
Secondary endpoints are:
• expert-based NYHA classification
• questionnaire-based NYHA classification
• QOL (MLHFQ and SF-36 questionnaires)
• structural and functional characteristics of the heart through
echocardiography (e.g. left ventricular dimensions and LVEF)
• biomarker levels (e.g. NT-proBNP)
• simultaneous registered ECG and blood pressure signals and consequential
characteristics (e.g. heart rate variability)
• PPG and accelerometer signals
• exercise tolerance according to 6MWT and (spiro-)ergometry (e.g. percentage
capacity)
• hospitalization for HF
• LVAD implantation
• heart transplantation
• mortality
Background summary
Heart failure (HF) is a complex clinical syndrome of signs and symptoms due to
a structural or functional abnormality of the heart leading to inadequate
pumping function. The functional state of the patient, i.e. the ability to do
the daily activities, plays an important role in HF. Classification of HF using
the New York Heart Association (NYHA) is based on symptoms and perception of
exercise tolerance. In addition to the assessment of severity of the symptoms
upon diagnosis, the NYHA classification is also used to monitor response to
treatment and is a predictor of mortality. Although the NYHA classification
itself has proved to be clinically useful, the way of classifying HF patients,
based on the patient*s and physician*s perception of exercise intolerance, is
inaccurate. Therefore, a need is seen in a new classification model for HF
patients which is based on multiple, objective, and clinically relevant
measures covering multiple aspects of the HF syndrome.
Study objective
The primary objective of this study is to develop an objective, clinical
relevant classification model of disease severity for patients with HF based on
an extensive, complete dataset of patients with HF.
Study design
The study is a prospective, non-randomized, observational, single-center study.
Study burden and risks
In this study, 278 patients will be included that represent a cross-section of
the outpatient heart failure patient population in the Cardiology department of
the Catharina Hospital. All of these patients will undergo multiple
measurements at the Catharina Hospital during the patient*s outpatient visit,
i.e. echocardiography, blood withdrawal for biomarker level analysis, and QOL
assessment through questionnaires. Additionally, in a subgroup of participants
ergometry or spirometry and simultaneous ECG, blood pressure, PPG and
accelerometer data of participating patients will be collected.
The risks associated with this study are negligible. The study consists of
measurements that are part of standard clinical care. Only the combination of
all the measurements is unusual in the outpatient clinical care. Since the data
obtained by this study may result in a method to classify and monitor patients
with heart failure in an objective manner in the future, and since the manner
in which the data is obtained is identical to already delivered standard care
(whether or not in the combination, as done in this study), we believe that
this research is warranted.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must have (suspected) heart failure (based on ESC guidelines 2016), is scheduled for a cardiac ultrasound, has not had cardiothoracic surgery within 90 days prior to moment of inclusion, must have the minimum age of 18 years, and must be able to provide informed consent.
Exclusion criteria
A potential subject will be excluded from the study if the patient is pregnant or when the subject has terminal heart failure with a life expectancy of several weeks.
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 | NL60579.100.17 |
| OMON | NL-OMON28510 |