Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03262675; https://ichgcp.net/clinical-trials-registry/NCT03262675.

International registered report identifier (irrid): DERR1-10.2196/12262.

Keywords: acute heart failure; chronic heart failure; diagnosis; heart failure; prognosis; treatment.

Conflict of interest statement

Conflicts of Interest: None declared.

©Leila Abid, Ikram Kammoun, Manel Ben Halima, Salma Charfeddine, Hedi Ben Slima, Meriem Drissa, Khadija Mzoughi, Dorra Mbarek, Leila Riahi, Saoussen Antit, Afef Ben Halima, Wejdene Ouechtati, Emna Allouche, Mehdi Mechri, Chedi Yousfi, Ali Khorchani, Omar Abid, Kais Sammoud, Khaled Ezzaouia, Imen Gtif, Sana Ouali, Feten Triki, Sonia Hamdi, Selim Boudiche, Marwa Chebbi, Mouna Hentati, Amani Farah, Habib Triki, Houda Ghardallou, Haythem Raddaoui, Sofien Zayed, Fares Azaiez, Fadwa Omri, Akram Zouari, Zine Ben Ali, Aymen Najjar, Houssem Thabet, Mouna Chaker, Samar Mohamed, Marwa Chouaieb, Abdelhamid Ben Jemaa, Haythem Tangour, Yassmine Kammoun, Mahmoud Bouhlel, Seifeddine Azaiez, Rim Letaief, Salah Maskhi, Aymen Amri, Hela Naanaa, Raoudha Othmani, Iheb Chahbani, Houcine Zargouni, Syrine Abid, Mokdad Ayari, Ines ben Ameur, Ali Gasmi, Nejeh ben Halima, Habib Haouala, Essia Boughzela, Lilia Zakhama, Soraya ben Youssef, Wided Nasraoui, Mohamed Rachid Boujnah, Nadia Barakett, Sondes Kraiem, Habiba Drissa, Ali Ben Khalfallah, Habib Gamra, Salem Kachboura, Leila Bezdah, Hedi Baccar, Sami Milouchi, Wissem Sdiri, Skander Ben Omrane, Salem Abdesselem, Alifa Kanoun, Karima Hezbri, Faiez Zannad, Alexandre Mebazaa, Samir Kammoun, Mohamed Sami Mourali, Faouzi Addad. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.10.2021.