Clinical trial NCT03262675: NAtional TUnisian REgistry of Heart Failure
Official title: National Tunisian Registry of Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Acute Heart Failure
Chronic Heat Failure
Cardiovascular diseases
Heart diseases
Registry
Tunisia
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
First posted: 2017-08-25
Enrollment: 2040
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular death
timeFrame: Time-To-Event measure up to 12 months from baseline
Secondary outcomes:
measure: Heart Failure Readmission
timeFrame: At 1, 3 and 12 months from patient enrollment
measure: Global Death
timeFrame: Time-To-Event measure up to 12 months from baseline
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
state: Tunisie
Study officials:
affiliation: Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
name: Faouzi Addad, Professor
role: STUDY_CHAIR
References:
citation: 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. Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study. JMIR Res Protoc. 2021 Oct 27;10(10):e12262. doi: 10.2196/12262.