NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.
The NATURE-HF is a national clinical non-interventional registry of heart failure, carried out in Tunisia at cardiology departments in hospitals and in liberal cardiology consultations. 100 cardiologists participate in the enrollment of the eligible patients as investigators. A Committee of Experts validates the protocol methodology and supervises the data-management. A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
Study Type
OBSERVATIONAL
Enrollment
2,040
Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
Tunis, Tunisie, Tunisia
Cardiovascular death
Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke
Time frame: Time-To-Event measure up to 12 months from baseline
Heart Failure Readmission
Incidence of heart failure readmissions
Time frame: At 1, 3 and 12 months from patient enrollment
Global Death
Incidence of death of all causes (cardiovascular death and non-cardiovascular death)
Time frame: Time-To-Event measure up to 12 months from baseline
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