Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386042
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
Guideline Implementation and Quality of Care in Patients With Heart Failure the TITRATE-HF Registry
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Guideline Implementation and Quality of Care in Patients With Heart Failure the TITRATE-HF Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TITRATE-HF
Brief Summary:
SUMMARY Rationale Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice
Objective The overall aim of the project is to study the titration of guideline directed medical therapy GDMT according to the European Society of Cardiology ESC HF 2021 guideline recommendations for patients with heart failure HF reduced ejection fraction HFrEF and mildly reduced ejection fraction HFmrEF
Study design The current study is a prospective multi-center national quality of care registry longitudinal of regular HF care as given
Study population The study population consists of patients with heart failure de novo HF chronic HF and worsening HF Study setting is outpatient or inpatient during admission Patient sample is set at a minimum of 4000 patients but can be expanded during the course of the registry project
Participating sites all hospitals with dedicated HF outpatient clinic in the Netherlands can participate
Data aggregated data
Intervention none no
Main study parametersendpoints The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage drug prescription percentage target dose order speed and reason not to adhere to the guideline intolerance side-effects maximum tolerated dose The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness There is no risk in participation no intervention and no active involvement of patients for specific activities in the study The project is a registration of care as given standard care to the participating subject with heart failure
Objective The overall aim of the project is to study the titration of guideline directed medical therapy GDMT according to the European Society of Cardiology ESC HF 2021 guideline recommendations for patients with heart failure HF reduced ejection fraction HFrEF and mildly reduced ejection fraction HFmrEF
Study design The current study is a prospective multi-center national quality of care registry longitudinal of regular HF care as given
Study population The study population consists of patients with heart failure de novo HF chronic HF and worsening HF Study setting is outpatient or inpatient during admission Patient sample is set at a minimum of 4000 patients but can be expanded during the course of the registry project
Participating sites all hospitals with dedicated HF outpatient clinic in the Netherlands can participate
Data aggregated data
Intervention none no
Main study parametersendpoints The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage drug prescription percentage target dose order speed and reason not to adhere to the guideline intolerance side-effects maximum tolerated dose The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up
Nature and extent of the burden and risks associated with participation benefit and group relatedness There is no risk in participation no intervention and no active involvement of patients for specific activities in the study The project is a registration of care as given standard care to the participating subject with heart failure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None