Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction

Overview

The purpose of the study is to investigate the clinical and morphological characteristics of chronic subclinical inflammation in the myocardium in patients with decompensated heart failure with ischemic systolic dysfunction.

Full Title of Study: “Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2018

Detailed Description

Important reason for the development of chronic heart failure is a viral disease of the heart, the three phenotypes associated with: the presence of inflammation without viral agent, implying an autoimmune disease; presence of inflammation and persistent viruses; and the presence of persistent virus without signs of inflammation. There is a group of patients with coronary heart disease, which on the background of optimal treatment is observed progression of clinical symptoms of coronary heart disease with the subsequent development of heart failure, leading to ischemic cardiomyopathy. Perhaps the reason for this is the combination of inflammatory and ischemic cardiomyopathies. Inflammatory cardiomyopathy, involved in the pathogenesis of DCM, includes idiopathic, autoimmune and infectious subtypes. Inflammatory disease of the myocardium diagnosed by established histological, immunological and immunohistochemical criteria. This study will include 60 patients with decompensated heart failure with ischemic left ventricular systolic dysfunction (LVEF <40%) were hospitalized not earlier than 6 months after myocardial revascularization. This group of patients will receive standard treatment, according to national guidelines RSC and ESC, to stabilize heart failure. All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy as a result of immunohistochemical studies will be made on the separation of the virus and the virus-negative-positive group. After that, the group will be divided into subgroups: virus – and inflammation in the myocardium inflammation without viral antigen, viral inflammation of the presence of antigen and the group with the presence of viral antigen without any signs of inflammation in the myocardium. The study is nonrandomized.

Interventions

  • Procedure: Endomyocardial biopsy
    • Endomyocardial biopsy will be performed through a puncture in the femoral vein. 3-6 samples taken under the control of myocardial echocardiography or flyuroskopii. Samples of biopsy material then transmitted Pathomorphology for immunohistochemistry, light microscope.

Arms, Groups and Cohorts

  • Other: chronic inflammation
    • All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of inflammatory infiltrate in the myocardial tissue
    • Time Frame: 6 month after PCI or CABG

Secondary Measures

  • Incidence of the virus – positive inflammatory infiltrate in the myocardial tissue
    • Time Frame: 6 month after PCI or CABG
  • The most frequent viral agents in myocardial tissue in this region
    • Time Frame: 6 month after PCI or CABG
  • Incidence of the acute myocardial infarction
    • Time Frame: 6 and 12 month after PCI or CABG
  • Incidence of disturbance rhythm and conduction of the heart
    • Time Frame: 6 and 12 month after PCI or CABG
  • Left ventricular ejection fraction (Echo)
    • Time Frame: 6 and 12 month after PCI or CABG
  • Еnd-diastolic volume of the left ventricle (Echo)
    • Time Frame: 6 and 12 month after PCI or CABG
  • Еnd-systolic volume of the left ventricle (Echo)
    • Time Frame: 6 and 12 month after PCI or CABG
  • Incidence of the mortality
    • Time Frame: 6 and 12 month after PCI or CABG
  • Incidence of the stroke
    • Time Frame: 6 and 12 month after PCI or CABG
  • Incidence of hospitalizations for decompensation heart failure
    • Time Frame: 6 and 12 month after PCI or CABG

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women over the age of 18 years old and weighing up to 130 kg – Clinical symptoms of decompensated heart failure in history – Heart failure decompensation requiring hospitalization for at least 3 of the following symptoms: shortness of breath, or position orthopnea, rales, peripheral edema, jugular venous pulsations, signs of stagnation in the pulmonary circulation according to the X-ray of the chest – Confirmed coronary heart disease with diastolic dysfunction (LVEF <40%) in history and at the time of admission – The term of the inclusion of patients in the study did not earlier than six months after revascularization (PCI or CABG) – Patients receiving medical treatment according to national guidelines RSC and ESC with individually tailored doses of drugs Exclusion Criteria:

  • The refusal of a patient to conduct the necessary studies – Poor visualization of the heart when ultrasound – Hemodynamically significant valvular heart disease – Acute coronary syndrome – Тhrombosis of the right atrium and right ventricle – Condition after the operation, impeding access to the right ventricle (cava filters plication vena cava, Mustard or Senning operation on the d-transposition of the great arteries, a mechanical prosthetic tricuspid valve) – Severe comorbidities

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Russian Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vyacheslav Ryabov, MD,PhD Research Institute for Cardiology – Russian Academy of Medical Sciences
  • Overall Official(s)
    • Vyacheslav Ryabov, MD, PhD, Principal Investigator, Research Institute for Cardiology
  • Overall Contact(s)
    • Vyacheslav Ryabov, MD, PhD, +73822553689, rvvt@cardio-tomsk.ru

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.