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…
ID
Bron
Verkorte titel
Aandoening
Heart failure regardless of etiology and heart failure type
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess the predictive value of different physical activity parameters, measured with a wrist-worn data logger, in deterioration of heart failure.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Continuous data (24/7) for a period of 3 months after hospital discharge due to an episode of acute decompensated heart failure.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9038 |
Ander register | METC MMC (study received a waiver that ethical approval was not required) : N19.049 |