NAtional TUnisian REgistry of Heart Failure (NATURE-HF)

National Tunisian Registry of Heart Failure

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

Study Overview

• Status: Completed
• Conditions: Heart Failure

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 Type: Observational
• Enrollment (Actual): 2040

Contacts and Locations

Study Locations

• Tunisia
  • Tunisie
    • Tunis, Tunisie, Tunisia, 1000
      • Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Readmission	Incidence of heart failure readmissions	At 1, 3 and 12 months from patient enrollment
Global Death	Incidence of death of all causes (cardiovascular death and non-cardiovascular death)	Time-To-Event measure up to 12 months from baseline

Collaborators and Investigators

• Sponsor: Dacima Consulting
• Collaborators: Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire
• Investigators: Study Chair: Faouzi Addad, Professor, Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): November 22, 2017
• Study Completion (Actual): January 12, 2019

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Registry; Cardiovascular diseases; Heart diseases; Acute Heart Failure; Tunisia; Chronic Heat Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DAC-002-NATUREHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical Study Report
• IPD Sharing Time Frame: Already available
• IPD Sharing Access Criteria: Free access
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No