Status:
COMPLETED
Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18-100 years
Brief Summary
This was a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient tr...
Detailed Description
This study aimed to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adul...
Eligibility Criteria
Inclusion
- Patients who provide written informed consent to participate in the study
- Male or female patients ≥ 18 years of age
- Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
- Decompensation event up to three months prior to inclusion
Exclusion
- Simultaneous or planned participation in an interventional research study
- Participation in this study at another site e.g. in a HFU network
- Patients incapable of understanding and signing the informed consent form
Key Trial Info
Start Date :
April 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
899 Patients enrolled
Trial Details
Trial ID
NCT06004453
Start Date
April 3 2023
End Date
January 17 2025
Last Update
December 5 2025
Active Locations (94)
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1
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, Germany, 69115
2
Novartis Investigative Site
Ludwigsburg, Baden-Wurttemberg, Germany, 71640
3
Novartis Investigative Site
Muellheim Im Markgraeflerland, Baden-Wurttemberg, Germany, 79379
4
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany, 60590