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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline recommended drug therapy for HFrEF with mirror information to HCP | Guideline recommended drug therapy for HFrEF with mirror information to HCP | ||
| Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient | Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient. |
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| Measure | Description | Time Frame |
|---|---|---|
| The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients. | 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) | 1 year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The % of target dose of GDMT prescribed in de novo HFrEF patients | The dosing level of a GDMT drug class as % of the guideline recommended dose during 1 year of follow-up. | 1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months). |
| Incident events |
| Measure | Description | Time Frame |
|---|---|---|
| GDMT adherence in subgroups of age (elderly) and sex (men/women) | GDMT adherence in subgroups of age (elderly) and sex (men/women) | 12 months |
Inclusion Criteria:
Exclusion Criteria:
At enrollment the patient has heart failure with reduction ejection fraction with an established EF below 40%.
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Patients with de novo / newly diagnosed heart failure with reduced ejection fraction
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fleur Wildenbeest | Contact | +31107040704 | f.wildenbeest@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rudolf de Boer, MD PhD | Erasmus Medical Center | Study Chair |
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The project is part of the NHR HF registry and follow the protocols and rules of the NHR on IPD accordingly (including GDPR/AVG), when applicable.
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The incidence of all-cause mortality and HF hospitalisations during 12 months of follow-up (and the individual components of the composite outcome). |
| 1 year of follow-up (12 months) |