NCT02649517

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Decompensated Heart Failure
• Ischemic Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-02-01
• Completion: 2018-10-01
• First posted: 2016-01-07
• Last updated: 2016-01-07

Locations

2 sites across 1 country: Russia