NATional TUnisian REgistry of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— NATURE-AF  

Official title:

National Tunisian Registry of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085576
• Other study ID #: DAC-001-NATUREAF
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2021
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.

Description:

The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 91 cardiologists participate in the selection of patients as investigators. The study is a longitudinal non-interventional registry of atrial fibrillation. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: July 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a rhythmic holter (duration of the episode: 30 seconds or more)

• Recent atrial fibrillation diagnosed for less than a year

• Regular monitoring every 3 months is ensured

• Informed, read and signed consent

Exclusion Criteria:

• Estimated life expectancy at less than 12 months

• Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction, following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary embolism or other acute pulmonary disease, pericarditis, myocarditis, hydro-electrolyte disorder, metabolic disorder)

• Cardiac surgery = 3 months

• Atrial flutter isolated without atrial fibrillation

• Mental disorders

• Ongoing anticoagulation for reasons other than atrial fibrillation

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Tunisia	STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Dacima Consulting	Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

Ben Halima A, Ouali S, Mourali MS, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Larbi N, Krichène S, Marrakchi S, Kacem S, Chrigui R, Abbes MF, Baccar H, Baraket N, Ben Halima N, Ben Khalfallah A, Ben Mbarek M, Ben Youssef S, Boughzala E, Boujnah MR, Drissa H, Gamra H, Gasmi A, Haouala H, Harrath Y, Issa I, Jeridi G, Kachboura S, Kammoun S, Kraiem S, Maatouk F, Milouchi S, Nasraoui W, Neji A, Sayahi K, Sdiri W, Smati W, Tlili S, Abid L, Abdesselem S, Zakhama L, Mahdhaoui A, Kammoun H, Ben Omrane S, Addad F. Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial. JMIR Res Protoc. 2018 Oct 15;7(10):e181. doi: 10.2196/resprot.8523. — View Citation

Ouali S, Ben Halima A, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Krichane S, Noureddine L, Marrakchi S, Charfeddine S, Hassine M, Sayahi K, Abbes Mohamed F, Nasraoui W, Ajmi H, Ben Miled M, Jebbari Z, Meghaieth MA, Allouche E, Mechmeche R, Zakhama L, Sdiri W, Ben Khalfallah A, Gharbi A, Milouchi S, Neji A, Antit S, Battikh K, Drissa M, Kaabachi S, Najar T, Tlili R, Chahbani I, Charfeddine H, Ben MM, Braham S, Maatouk F, Abdesselem S, Ayari M, Garbaa R, Hamrouni N, Mbarek D, Rekik H, Zaghdoudi H, Ayadi W, Baraket F, Ben Brahim K, Ben Romdhane M, Bousadia H, Brahim W, Mezri M, Guesmi A, Ounissi T, Kammoun S, Smati W, Tlili S, Zoughi K, Zemni J, Cheikh Bouhlel M, Islem S, Jemli R, Joulak A, Mzoughi K, Naanea H, Hached L, Hadrich M, Hmem M, Kacem S, Kammoun I, Othmani R, Ouerghi A, Abid S, Ennouri R, Haidar S, Heraiech S, Jammali M, Jarrar M, Riahi L, Trimech B, Azaiez MA, Azzouzi F, Ben Jemaa K, Ben Rejab O, Chrigui R, Wechtati W, Boughzela E, Jridi G, Bezdah L, Kraiem S, Drissa H, Ben Youssef S, Fehri W, Kachboura S, Gamra H, Kammoun S, Mourali MS, Addad F, Abid L. Epidemiological characteristics, management, and outcomes of atrial fibrillation in TUNISIA: Results from the National Tunisian Registry of Atrial Fibrillation (NATURE-AF). Clin Cardiol. 2021 Apr;44(4):501-510. doi: 10.1002/clc.23558. Epub 2021 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death	Number of patients with ischemic stroke and/or transient ischemic attack, and/or arterial embolization during the follow-up period	Every 3 months up to 1 year
Secondary	Haemorrhagic accidents	All bleeding events (digestive, cerebral, other locations)	Every 3 months up to 1 year
Secondary	Measurement of INR (International Normalized Ratio)	INR measurement of venous blood sampling	Every month for 1 year
Secondary	TTR (percent Time in Therapeutic INR Range)	The mean TTR obtained in patients who received anticoagulant therapy	1 year

External Links

•   Association between atrial fibrillation symptoms and patient outcome
•   Gender differences in presentation and treatment of patients with atrial fibrillation: Results from the Nature AF registry
•   Influence of renal function on vitamin K antagonist oral anticoagulation quality in non-valvular atrial fibrillation patien
•   Medscape : A first register on AF in the Maghreb
•   National Tunisian Registry of Atrial Fibrillation (NATURE-AF): Baseline results
•   Prevalence and characteristics of valvular heart disease of patients with atrial fibrillation: Results from the NATURE AF registry
•   SAMe-TT2R2 in tunisian population: Results from the NATURE AF registry
•   Treatment strategies in geriatric patients with atrial fibrillation: Results from the NATURE AF registry