HaFaC study
Recruiting
- Conditions
- Heart FailureNYHA classification
- Registration Number
- NL-OMON28510
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 278
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br /><br><br /><br>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<br>mortality, heart transplantation or Left Ventricular Assist Device (LVAD) implantation.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are:<br /><br>• expert-based NYHA classification<br /><br>• questionnaire-based NYHA classification<br /><br>• QOL (MLHFQ and SF-36 questionnaires)<br /><br>• structural and functional characteristics of the heart through echocardiography (e.g. left ventricular dimensions and LVEF)<br /><br>• biomarker levels (e.g. NT-proBNP)<br /><br>• simultaneous registered ECG and blood pressure signals and consequential characteristics (e.g. heart rate variability)<br /><br>• PPG and accelerometer signals<br /><br>• exercise tolerance according to 6MWT and (spiro-)ergometry (e.g. percentage capacity)<br /><br>• hospitalization for HF<br /><br>• LVAD implantation<br /><br>• heart transplantation<br /><br>• mortality