NAtional TUnisian REgistry of Heart Failure — NATURE-HF  

Heart Failure Clinical Trial

Official title: National Tunisian Registry of Heart Failure

Status Completed

Clinical Trial Summary

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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT03262675
• Study type: Observational [Patient Registry]
• Source: Dacima Consulting
• Status: Completed
• Start date: October 16, 2017
• Completion date: January 12, 2019