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

Russian Academy of Medical Sciences (RAMS)

Status

Unknown

Conditions

Ischemic Heart Disease

Decompensated Heart Failure

Treatments

Procedure: Endomyocardial biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02649517

1801

Details and patient eligibility

About

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 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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