Clinical and morphological characteristics of chronic inflammation in the myocardium in patients with decompensated chronic heart failure accompanied by ischemic systolic dysfunction: study protocol for an open-label nonrandomized trial

Abstract

Background: Heart failure is one of the leading causes of morbidity and mortality in the world. Mortality remains high (50%), despite optimal treatment according to the recommendations of the European Society of Cardiology (ESC) and Russian Society of Cardiology (RSC). Tremendous evidence has emerged over the past decades that heart failure is associated with inflammation. However, anti-inflammatory therapy widely lacks positive outcomes. Currently, there are no clinical studies investigating the molecular and cellular phenotypes of inflammation in myocardial tissue (viral, viral and autoimmune, and autoimmune types of inflammation) in patients with decompensated chronic heart failure (CHF). Therefore this study aims to develop a new medicinal drugs and approaches to treatment of decompensated CHF. Methods/Design: This open-label, nonrandomized, single-center, prospective trial includes decompensated CHF patients with ischemic systolic dysfunction (left ventricular ejection fraction < 40%) undergoing percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) not earlier than 6 months before hospitalization. This group of patients will receive standard treatment of acute decompensated CHF according to RSC national guidelines and ESC guidelines. All patients will undergo coronary angiography to exclude ischemic etiology of decompensated CHF and endomyocardial biopsy to determine type of inflammation in the myocardium by immunohistochemistry. The following parameters are assessed during hospitalization and at 12-month follow-up: inflammatory infiltrate in the myocardial tissue, incidence of acute myocardial infarction, incidence of cardiac rhythm and conduction disturbances, left ventricular ejection fraction, end-diastolic and end-systolic volumes, mortality rate, incidence of stroke, and the rates of hospital admission due to the progression of CHF. Discussion: Elucidation of inflammatory infiltrate types in the myocardium and determination of frequency of their occurrences in patients with decompensated CHF and ischemic systolic dysfunction will contribute to the development of new pharmacological approaches to CHF treatment. Trial registration: ClinicalTrials.gov Identifier: NCT02649517; registered on January 5, 2016. Ethics: The study protocol follows the Declaration of Helsinki and has been approved by the Ethics Committee of the authors' institution on April 20, 2015. The study complies with the National Standard of Good Clinical Practice (RF GOST P52379-2005 form April 1, 2006) and with the international guidelines for Good Clinical Practice. Informed consent: Investigators or investigator-authorized officers will be responsible for explaining the objective, content, study procedures, benefits, and risks of participating in the clinical trial to each patient or the patient's legal representative. Written informed consent will be obtained from all patients before the start of the trial.