NAtional TUnisian REgistry of Heart Failure

Heart Failure Clinical Trial

— NATURE-HF  

Official title:

National Tunisian Registry of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262675
• Other study ID #: DAC-002-NATUREHF
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: January 12, 2019

Study information

• Verified date: January 2020
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2040
• Est. completion date: January 12, 2019
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Tunisia	Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire	Tunis	Tunisie

Sponsors (2)

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

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular death	Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke	Time-To-Event measure up to 12 months from baseline
Secondary	Heart Failure Readmission	Incidence of heart failure readmissions	At 1, 3 and 12 months from patient enrollment
Secondary	Global Death	Incidence of death of all causes (cardiovascular death and non-cardiovascular death)	Time-To-Event measure up to 12 months from baseline

External Links

•   Epidemiological profile and pronostic impact of patients with heart failure and atrial fibrillation: Results from the NATURE HF registry
•   Epidemiology, management, and outcomes of heart failure in Tunisia: Results from the Nature-HF registry
•   Impact of diabetes on heart failure outcomes: Results from NATURE-HF
•   Influence of age on the treatment of heart failure (HF) with reduced ejection fraction: From a Tunisian registry NATURE HF
•   Influence of chronic kidney disease on patients with heart failure outcome
•   Management of Heart Failure (HF): Is there a difference in genders? 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