Heart FailureNATURE-HFNCT03262675
NAtional TUnisian REgistry of Heart Failure
An observational study of Heart Failure, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 2,040 participants
- Where
- 1 siteTunisia
- Study dates
- 16 Oct 2017to 12 Jan 2019
- 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 heart failure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
Tunis, Tunisie, 1000
About this study
Official title: National Tunisian Registry of Heart Failure
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.
Read the 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
- Heart Failure
- Keywords
- Heart Failure, Acute Heart Failure, Chronic Heat Failure, Cardiovascular diseases, Heart diseases, Registry, Tunisia
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke
Measured: Time-To-Event measure up to 12 months from baseline
Secondary outcomes (2)
Heart Failure Readmission
Incidence of heart failure readmissions
Measured: At 1, 3 and 12 months from patient enrollment
Global Death
Incidence of death of all causes (cardiovascular death and non-cardiovascular death)
Measured: Time-To-Event measure up to 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start16 Oct 2017
- Primary completion22 Nov 2017
- Study completion12 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 2,040 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
- NCT03262675
- Sponsor's protocol ID
- DAC-002-NATUREHF
- Acronym
- NATURE-HF
- Status last verified
- Jan 2020
- First submitted
- 22 Aug 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical Study Report
Publications
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.
PubMed 34704958
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Registry of Heart Failure
- ClinicalTrials.gov ID
- NCT03262675
- Acronym / sponsor ID
- NATURE-HF / DAC-002-NATUREHF
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Acute Heart Failure, Chronic Heat Failure, Cardiovascular diseases, Heart diseases, Registry, Tunisia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,040 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 12 Jan 2019 (actual)
- First posted
- 25 Aug 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.
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).
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 heart failure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Life expectancy <12 months for extra cardiac disease
- Isolated Right Heart Failure
- Pregnant woman
- Renal failure with creatinine clearance < 15 ml / min
- Hemodialysis patients
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
Cardiovascular death
Time frame: 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
2 secondary outcomes
Heart Failure Readmission
Time frame: At 1, 3 and 12 months from patient enrollment
Global Death
Time frame: Time-To-Event measure up to 12 months from baseline
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 22 Jan 2020.
- Derived from this study: PubMed 34704958Abid 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.
- Individual participant dataSharing planned: Yes. Clinical Study Report
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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 Heart Failure, 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 7 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 22 Jan 2020. 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?
Cardiovascular death (time frame: Time-To-Event measure up to 12 months from baseline). 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 NCT03262675, which also lists 1 linked publication.
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 22 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.