Atrial FibrillationNATURE-AFNCT03085576
NATional TUnisian REgistry of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 910 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2017to 30 Jul 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
STCCCV - Société Tunisienne de Cardiologie et de Chirurgie Cardio-Vasculaire
Tunis, 1053
About this study
Official title: National Tunisian Registry of Atrial Fibrillation
A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
Read the detailed 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Anticoagulation, Stroke, Vitamin K antagonist, Cardioversion, INR (International Normalized Ratio)
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 3 months up to 1 year
Secondary outcomes (3)
Haemorrhagic accidents
All bleeding events (digestive, cerebral, other locations)
Measured: Every 3 months up to 1 year
Measurement of INR (International Normalized Ratio)
INR measurement of venous blood sampling
Measured: Every month for 1 year
TTR (percent Time in Therapeutic INR Range)
The mean TTR obtained in patients who received anticoagulant therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Mar 2017
- Primary completion30 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 910 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
- Responsible party
- Sponsor
- Investigators
- Faouzi Addad, Professor, Study chair, Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085576
- Sponsor's protocol ID
- DAC-001-NATUREAF
- Acronym
- NATURE-AF
- Status last verified
- Apr 2021
- First submitted
- 5 Mar 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben Halima A, Ouali S, Mourali MS, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Larbi N, Krichene 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.
PubMed 30322836Ouali 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.
PubMed 33704830
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Registry of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03085576
- Acronym / sponsor ID
- NATURE-AF / DAC-001-NATUREAF
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Anticoagulation, Stroke, Vitamin K antagonist, Cardioversion, INR (International Normalized Ratio)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death
Time frame: Every 3 months up to 1 year
Number of patients with ischemic stroke and/or transient ischemic attack, and/or arterial embolization during the follow-up period
3 secondary outcomes
Haemorrhagic accidents
Time frame: Every 3 months up to 1 year
Measurement of INR (International Normalized Ratio)
Time frame: Every month for 1 year
TTR (percent Time in Therapeutic INR Range)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 30322836Ben Halima A, Ouali S, Mourali MS, Chabrak S, Chettaoui R, Ben Halima M, Haggui A, Larbi N, Krichene 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.
- Background: PubMed 33704830Ouali 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.
- Prevalence and characteristics of valvular heart disease of patients with atrial fibrillation: Results from the NATURE AF registryLink provided by the sponsor.
- Treatment strategies in geriatric patients with atrial fibrillation: Results from the NATURE AF registryLink provided by the sponsor.
- Gender differences in presentation and treatment of patients with atrial fibrillation: Results from the Nature AF registryLink provided by the sponsor.
- SAMe-TT2R2 in tunisian population: Results from the NATURE AF registryLink provided by the sponsor.
- Association between atrial fibrillation symptoms and patient outcomeLink provided by the sponsor.
- Influence of renal function on vitamin K antagonist oral anticoagulation quality in non-valvular atrial fibrillation patienLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faouzi Addad, Professor study chair
Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke or transient ischemic attack, thromboembolic events and cardiovascular death (time frame: Every 3 months up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.