Trials / Completed
CompletedNCT03262675
NAtional TUnisian REgistry of Heart Failure
National Tunisian Registry of Heart Failure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,040 (actual)
- Sponsor
- Dacima Consulting · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.
Detailed 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).
Conditions
Timeline
- Start date
- 2017-10-16
- Primary completion
- 2017-11-22
- Completion
- 2019-01-12
- First posted
- 2017-08-25
- Last updated
- 2020-01-22
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT03262675. Inclusion in this directory is not an endorsement.