Abstract
BackgroundHeart failure is a highly prevalent disease with a global prevalence of 37 million, and the prevalence is increasing. Patients with heart failure are at an increased risk of death and morbidity. Traditionally, patients with heart failure have been treated with a beta-blocker in addition to an inhibitor of the renin-angiotensin-aldosterone system. However, new drugs are currently being added to the recommended guideline therapy. The latest drug to be added combines inhibition of the renin-angiotensin-aldosterone system pathway with inhibiting the neprilysin enzyme and is therefore classified as an ARNI. Our objective is to identify the beneficial and harmful effects of ARNIs in the treatment of patient with heart failure.MethodsThis protocol for a systematic review was undertaken using the recommendations of the Cochrane, the Preferred Report Items of Systematic reviews with Meta-Analysis Protocols, and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the use of ARNIs in the treatment of patients with heart failure. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded on Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science Journal Database (VIP), and BIOSIS to identify relevant trials. We will also search for grey literature and unpublished trials. Extracted data will be analysed using Review Manager 5, STATA 5, and Trial Sequential Analysis. Our primary outcomes will be all-cause mortality and serious adverse events. We will create a ‘Summary of Findings’ table in which we will present our primary and secondary outcomes, and we will assess the quality of evidence using the GRADE assessment.DiscussionThe present systematic review will have the potential to aid clinicians in decision-making and thereby, benefit patients with heart failure.Systematic review registrationPROSPERO CRD42019129336
Highlights
Heart failure is a highly prevalent disease with a global prevalence of 37 million, and the prevalence is increasing
We have based the protocol on the Preferred Reported Items for Systematic reviews and Meta-Analyses Protocol (PRISMA-P) checklist [39, 41]
We have pre-defined our methodology based on the Cochrane Handbook for Systematic Reviews of Interventions [40], Keus et al [59], the eight-step assessment as suggested by Jakobsen et al [60], Trial Sequential Analysis [44], and Grading of Recommendations Assessment (GRADE) assessment [74, 76]
Summary
Heart failure is a highly prevalent disease with a global prevalence of 37 million, and the prevalence is increasing. Patients with heart failure are at an increased risk of death and morbidity. Patients with heart failure have been treated with a beta-blocker in addition to an inhibitor of the renin-angiotensin-aldosterone system. Common risk factors for developing heart failure are hypertension, coronary artery disease, diabetes mellitus, and metabolic syndrome [3]. Valvular disease, hypertension, and dilated cardiomyopathy serve as the main causes of heart failure in the majority of patients [18,19,20,21]. The left ventricular systolic dysfunction caused by, for example, tachycardia or myocarditis has shown to be reversible either partly or completely [22]
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