NAtional TUnisian REgistry of Heart Failure

Conditions

Heart Failure

Keywords

Heart Failure, Acute Heart Failure, Chronic Heat Failure, Cardiovascular diseases, Heart diseases, Registry, Tunisia

Brief 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).

Abid L, Kammoun I, Ben Halima M, Charfeddine S, Ben Slima H, Drissa M, Mzoughi K, Mbarek D, Riahi L, Antit S, Ben Halima A, Ouechtati W, Allouche E, Mechri M, Yousfi C, Khorchani A, Abid O, Sammoud K, Ezzaouia K, Gtif I, Ouali S, Triki F, Hamdi S, Boudiche S, Chebbi M, Hentati M, Farah A, Triki H, Ghardallou H, Raddaoui H, Zayed S, Azaiez F, Omri F, Zouari A, Ben Ali Z, Najjar A, Thabet H, Chaker M, Mohamed S, Chouaieb M, Ben Jemaa A, Tangour H, Kammoun Y, Bouhlel M, Azaiez S, Letaief R, Maskhi S, Amri A, Naanaa H, Othmani R, Chahbani I, Zargouni H, Abid S, Ayari M, Ben Ameur I, Gasmi A, Ben Halima N, Haouala H, Boughzela E, Zakhama L, Ben Youssef S, Nasraoui W, Boujnah MR, Barakett N, Kraiem S, Drissa H, Ben Khalfallah A, Gamra H, Kachboura S, Bezdah L, Baccar H, Milouchi S, Sdiri W, Ben Omrane S, Abdesselem S, Kanoun A, Hezbri K, Zannad F, Mebazaa A, Kammoun S, Mourali MS, Addad F.

2021-10-272 citations

10.2196/12262

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular death	Time-To-Event measure up to 12 months from baseline	Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke

Secondary

Measure	Time frame	Description
Heart Failure Readmission	At 1, 3 and 12 months from patient enrollment	Incidence of heart failure readmissions
Global Death	Time-To-Event measure up to 12 months from baseline	Incidence of death of all causes (cardiovascular death and non-cardiovascular death)

Countries

Tunisia

Outcome results