Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study (Preprint)
Authors: Abid Leila , Kammoun Ikram , Ben Halima Manel , Charfeddine Salma , Ben Slima Hedi , Drissa Meriem , Mzoughi Khadija , Mbarek Dorra , Riahi Leila , Antit Saoussen , Ben Halima Afef , Ouechtati Wejdene , Allouche Emna , Mechri Mehdi , Yousfi Chedi , Khorchani Ali , Abid Omar , Sammoud Kais , Ezzaouia Khaled , Gtif Imen , Ouali Sana , Triki Feten , Hamdi Sonia , Boudiche Selim , Chebbi Marwa , Hentati Mouna , Farah Amani , Triki Habib , Ghardallou Houda , Raddaoui Haythem , Zayed Sofien , Azaiez Fares , Omri Fadwa , Zouari Akram , Ben Ali Zine , Najjar Aymen , Thabet Houssem , Chaker Mouna , Mohamed Samar , Chouaieb Marwa , Ben Jemaa Abdelhamid , Tangour Haythem , Kammoun Yassmine , Bouhlel Mahmoud , Azaiez Seifeddine , Letaief Rim , Maskhi Salah , Amri Aymen , Naanaa Hela , Othmani Raoudha , Chahbani Iheb , Zargouni Houcine , Abid Syrine , Ayari Mokdad , ben Ameur Ines , Gasmi Ali , ben Halima Nejeh , Haouala Habib , Boughzela Essia , Zakhama Lilia , ben Youssef Soraya , Nasraoui Wided , Boujnah Mohamed Rachid , Barakett Nadia , Kraiem Sondes , Drissa Habiba , Ben Khalfallah Ali , Gamra Habib , Kachboura Salem , Bezdah Leila , Baccar Hedi , Milouchi Sami , Sdiri Wissem , Ben Omrane Skander , Abdesselem Salem , Kanoun Alifa , Hezbri Karima , Zannad Faiez , Mebazaa Alexandre , Kammoun Samir , Mourali Mohamed Sami , Addad Faouzi 
Published: October 2018

BACKGROUND

The frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa).

OBJECTIVE

The aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial.

METHODS

A total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface.

RESULTS

At the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study.

CONCLUSIONS

The NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia.

CLINICALTRIAL

ClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/12262