NAtional TUnisian REgistry of Heart Failure (NATURE-HF)

DACIMA

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT03262675

DAC-002-NATUREHF

Details and patient eligibility

About

NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.

Full description

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).

Enrollment: 2,040 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with chronic heart failure
• Patient with acute heart failure (new onset or not)
• The diagnosis of heart failure is at the discretion of the investigator
• Informed and signed consent

Exclusion criteria

• Life expectancy <12 months for extra cardiac disease
• Isolated Right Heart Failure
• Pregnant woman
• Renal failure with creatinine clearance < 15 ml / min
• Hemodialysis patients
• Cardiac surgery planned within 3 months
• Congenital heart disease