Wearable Device-Assisted Remote Management in Atrial Fibrillation Complicated by Heart Failure: WARM-HF Trial
NCT07411170
AF - Atrial Fibrillation, Arrhythmias, Cardiac
View Trial DetailsNCT Number: NCT07702760
The IMPLEMENT HF study is part of the national heart failure quality of care registry (evaluation of given health care). Within the HF registry, the investigators will investigate whether mirror information on the actual 4 pillars of guideline directed medical therapy (GDMT) in HFrEF patients will help to further improve the implementation of GDMT.
Data will be used from the national HF registry in the Netherlands. Two groups will be studied, one where the HCP receives the mirror information on GDMT and one where both the patient and the HCP receive the mirror information on GDMT. GDMT or the 4 pillars treatment is standard of care as recommended by the ESC HF guidelines, indicated for all HFrEF patients. The project is a quality of care registry and health care evaluation to optimize adherence to the HF guidelines.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
The IMPLEMENT HF is a sequel study to the TITRATE HF study that has shown that the level of GDMT prescription in de novo HFrEF can be further improved. The investigators hypothesize that mirror information about actual levels of GDMT helps the physician and patient optimize GDMT as recommended in the guideline. The IMPLEMENT is a registry based study in 1500 with de novo HFrEF patients, in which mirror information on GDMT (4 pillars) prescription levels will be shown to the treating physician. In a second group (50%) both the physician and patient will receive the mirror information on the prescription of GDMT. For diversity, the investigators aim to include 50% elderly and 50% women in to the registry. The primary endpoint is the prescription level of GDMT. Secondary endpoints are the dosing levels of GDMT (% target dose) and incident clinical events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At enrollment the patient has heart failure with reduction ejection fraction with an established EF below 40%.
Time frame: 1 year of follow-up
The prescription level (%) of GDMT / 4 pillars in patients with de novo HFrEF at specific time moments durign 1 year (6 weeks, 3 Months , 6 Months, 12 Months)
Time frame: 1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).
The dosing level of a GDMT drug class as % of the guideline recommended dose during 1 year of follow-up.
Time frame: 1 year of follow-up (12 months)
The incidence of all-cause mortality and HF hospitalisations during 12 months of follow-up (and the individual components of the composite outcome).
Time frame: 12 months
GDMT adherence in subgroups of age (elderly) and sex (men/women)
Contact information is provided by the study sponsor or research team.
Jasper Brugts MD PhD
Other
Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF): The IMPLEMENT-HF Study.
Acronym: IMPLEMENT HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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