NAtional TUnisian REgistry of Heart Failure

NCT03262675 | Completed DMC

• 1 other identifier: DAC-002-NATUREHF
• Study Type: observational
• Target: 2,040
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure; Acute Heart Failure; Chronic Heat Failure; Cardiovascular diseases; Heart diseases; Registry; Tunisia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart Failure Readmission

  At 1, 3 and 12 months from patient enrollment

• Global Death

  Time-To-Event measure up to 12 months from baseline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dacima Consulting: lead
• Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire: collaborator

Study Sites (1)

Société Tunisienne de Cardiologie & de Chirurgie Cardio-Vasculaire

Tunis, Tunisie, 1000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 34704958 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Officials

• Faouzi Addad, Professor

  Société Tunisienne de Cardiologie et de Chirurgie Cardiovasculaire

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: October 16, 2017
• Primary Completion: November 22, 2017
• Study Completion: January 12, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Already available
• Access Criteria: Free access

Locations

TU (1)