Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 21, 2018
Date Accepted: Mar 24, 2019
Design and rationale of NATURE-HF : the NAtional TUnisian REgistry of Heart Failure
ABSTRACT
Background:
Heart failure (HF) is becoming a public health problem in Tunisia considering its current frequency and in the medium term, and this is mainly linked to an aging of the Tunisian population (the oldest population in Africa, with life expectancy higher) and decreased mortality of coronary and hypertensive patients. However, there is no extensive data available on the demographic, prognostic and quality of management of patients with heart failure in Tunisia (nor in North Africa).
Objective:
Therefore, the aim of this study was to analyze, follow and evaluate patients with HF in a large multicenter nation-wide trial.
Methods:
1700 patients with HF diagnosed by the investigator will be included in the NATURE HF registry. patients must go to the cardiology clinic after 1, 3 and 12 months after inclusion. This follow-up is provided by the investigator. The data are collected via the DACIMA Clinical SuiteĀ® web interface.
Results:
Results:
At the end of the study, we will note the occurrence of cardiovascular death (sudden death, CAD, refractory heart failure, stroke), death of any cause (cardiovascular and non-cardiovascular)and the occurrence of a re-hospitalization episode for a relapse heart failure during the follow-up period. therefore, we will find the demographic characteristics of the subjects of the study and their characteristics of pathological antecedents, the symptomatic and clinical features of heart failure and its exploratory characteristics (biological, ECG and / or rhythmic holter, ETT, coronarography) in the total population, a description of the therapeutic environment and therapeutic changes during one-year follow-up of the patients included, description of adverse events occurring through medical treatment and interventional during follow-up at 3 months and at 12 months, the evaluation of LVEF during follow-up at 3 months and at 12 months, the overall rate of rehospitalizations over one year of follow-up, for a relapse HF and the rate of re-hospitalization during the first 3 months after inclusion
Conclusions:
ClinicalTrials.gov Identifier:NCT03262675 (registered on 15 july 2017). Clinical Trial: ClinicalTrials.gov Identifier:NCT03262675 (registered on 15 july 2017).
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