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://clinicaltrials.gov/ct2/show/NCT03262675 International Registered Report Identifier (IRRID) DERR1-10.2196/12262

Assessing and Improving the Care of Patients With Heart Failure in Ghana: Protocol for a Prospective Observational Study and the Ghana Heart Initiative-Heart Failure Registry

“…Established in 2000 and implemented nationwide in Sweden by 2003, this registry has yielded valuable research outcomes that have led to notable improvements in the understanding and care of patients with HF and under-treatment detection [ 1 ]. The NAtional TUnisian REgistry of Heart Failure (NATURE-HF) contributed valuable data that have the potential to enhance the treatment and overall prognosis of individuals with HF in North Africa [ 34 ]. Valuable data were also derived from the Abeokuta Heart Failure Clinical Registry of patients presenting with acute HF in Abeokuta, Nigeria, including acute HF presenting at a relatively younger age, commoner in men, and associated with severe symptoms [ 35 ].…”

The Predictive Value of A, B, and C-Type Natriuretic Peptides in People at Risk of Heart Disease: Protocol for a Longitudinal Observational Study

“…We postulate that (1) participants with lower levels of ANP or BNP at age 50 years will exhibit more advanced cardiac and metabolic impairment 15 years later and (2) higher levels of CNP products at age 50 years will associate with more advanced vascular and myocardial degenerative disease at age 65 years. Although protocols for the study of the predictive value of data on cardiovascular outcomes have been reported in specific disease states such as heart failure [ 25 ] or psoriasis [ 26 ], no previous study examining the predictive value of natriuretic peptides on cardiovascular outcomes in participants without evidence of heart disease has been reported to date.…”