NATURE-HF: NAtional TUnisian REgistry of Heart Failure
Study Details
Study Description
Brief Summary
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with chronic heart failure
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Patient with acute heart failure (new onset or not)
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The diagnosis of heart failure is at the discretion of the investigator
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Informed and signed consent
Exclusion Criteria:
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Life expectancy <12 months for extra cardiac disease
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Isolated Right Heart Failure
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Pregnant woman
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Renal failure with creatinine clearance < 15 ml / min
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Hemodialysis patients
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Cardiac surgery planned within 3 months
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Congenital heart disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire | Tunis | Tunisie | Tunisia | 1000 |
Sponsors and Collaborators
- Dacima Consulting
- Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
Investigators
- Study Chair: Faouzi Addad, Professor, Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Management of Heart Failure (HF): Is there a difference in genders? Results from the NATURE-HF Registry
- Epidemiological profile and pronostic impact of patients with heart failure and atrial fibrillation: Results from the NATURE HF registry
- Influence of chronic kidney disease on patients with heart failure outcome
- Influence of age on the treatment of heart failure (HF) with reduced ejection fraction: From a Tunisian registry NATURE HF
- Impact of diabetes on heart failure outcomes: Results from NATURE-HF
- Epidemiology, management, and outcomes of heart failure in Tunisia: Results from the Nature-HF registry
- National Tunisian Registry of Atrial Fibrillation (NATURE-AF): Baseline results
- Real-life data on heart failure and implantation of resynchronization devices in Tunisia
Publications
None provided.- DAC-002-NATUREHF