No registrations found.
ID
Source
Brief title
Health condition
Heart Failure
NYHA classification
Sponsors and support
Catharina Onderzoeksfonds
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.
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. The study is a prospective, non-randomized, observational, single-center study. A cross-section of the outpatient HF population in the cardiology department will be included (n=278).
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.
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
baseline, 6 months, 12 months
Intervention
Observational
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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7268 |
NTR-old | NTR7466 |
CCMO | NL60579.100.17 |
OMON | NL-OMON45646 |