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ID
Source
Brief title
Health condition
Heart failure regardless of etiology and heart failure type
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the predictive value of different physical activity parameters, measured with a wrist-worn data logger, in deterioration of heart failure.
Secondary outcome
-
Background summary
To improve telemonitoring strategies in patients with chronic heart failure, there is a need for novel parameters and technologies to monitor these patients. Monitoring of physical activity and other parameters such as heart rate variability and sleep, might serve as a useful adjunct to the regular parameters being monitored. This is supported by previous studies in patients with an implantable cardioverter defibrillator (ICD), which showed that ICD parameters such as heart rate, heart rate variability and activity are predictive for heart failure readmissions. However, a substantial part of HF patients do not have an ICD or one that features activity monitoring. Therefore the aim of the present study is to evaluate the predictive value of several parameters measured with a wrist-worn data logger for deterioration of heart failure.
Study objective
We hypothesize that several parameters, measured with a wrist-worn data logger, will be predictive for a heart failure event.
Parameters which are taken into account are: heart rate, activity count, energy expenditure, but also parameters which are not related to physical activity, such as heart rate variability, respiratory rate and sleep parameters.
A heart failure event is defined as a hospital readmission or an uptitration of oral diuretics at the outpatient clinic, due to decompensated heart failure.
Study design
Continuous data (24/7) for a period of 3 months after hospital discharge due to an episode of acute decompensated heart failure.
Intervention
This is a single-center, prospective exploratory proof of concept study.
Patients who are admitted to Máxima Medical Centre due to an episode of decompensated heart failure, and who are meeting the other in- and exclusion criteria, are asked to participate in the present study.
If they consent to participate, they will be asked to wear a non-obtrusive, wrist-worn data logger (Philips Netherlands B.V.) for a period of 3 months from the moment of discharge from the hospital. They will be asked to wear the data logger 24/7 to gather photoplethysmography (PPG) and accelerometry data. These data are translated in several parameters such as: heart rate, heart rate variability, activity count, activity type, energy expenditure, respiratory rate and sleep data.
Patients do not receive feedback or coaching based on the recorded data. After three months the patient will hand in the data logger.
During follow-up the medical records of the participants will be periodically checked to report recurrent heart failure events. A heart failure event is defined as a hospital readmission, or an uptitration of oral diuretics at the outpatient clinic, due to decompensated heart failure.
Inclusion criteria
1. Diagnosed with heart failure (regardless of heart failure type and etiology)
2. Admitted to the hospital due to acute decompensated heart failure
3. Age ≥ 18 years
4. Able to speak and read the Dutch language
5. Willing and able to provide informed consent
Exclusion criteria
1. Permanent atrial fibrillation
2. Not able or willing to wear a wrist-worn data logger on a daily basis (for example due to work related obligations)
3. Major planned (cardiac) surgery in the upcoming 3 months
4. Not able to perform daily physical activity due to orthopedic of neurological disease
5. Bed/chair ridden patients
6. Presence of wounds, injuries or infectious diseases on the skin where the wrist-wearable device will be placed
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9038 |
| Other | METC MMC (study received a waiver that ethical approval was not required) : N19.049 |