Clinical trial NCT02649517: Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction
Official title: Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decompensated Heart Failure
Ischemic Heart Disease
Keywords: decompensated heart failure
ischemic heart disease
inflammatory cardiomyopathy
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of inflammatory infiltrate in the myocardial tissue
timeFrame: 6 month after PCI or CABG
Secondary outcomes:
measure: Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
timeFrame: 6 month after PCI or CABG
measure: The most frequent viral agents in myocardial tissue in this region
timeFrame: 6 month after PCI or CABG
measure: Incidence of the acute myocardial infarction
timeFrame: 6 and 12 month after PCI or CABG
measure: Incidence of disturbance rhythm and conduction of the heart
timeFrame: 6 and 12 month after PCI or CABG
measure: Left ventricular ejection fraction (Echo)
timeFrame: 6 and 12 month after PCI or CABG
measure: Еnd-diastolic volume of the left ventricle (Echo)
timeFrame: 6 and 12 month after PCI or CABG
measure: Еnd-systolic volume of the left ventricle (Echo)
timeFrame: 6 and 12 month after PCI or CABG
measure: Incidence of the mortality
timeFrame: 6 and 12 month after PCI or CABG
measure: Incidence of the stroke
timeFrame: 6 and 12 month after PCI or CABG
measure: Incidence of hospitalizations for decompensation heart failure
timeFrame: 6 and 12 month after PCI or CABG
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Research Institutite for Cardiology
state: Tomskii region
city: Tomsk
country: Russian Federation
facility: Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Study officials:
affiliation: Research Institute for Cardiology
name: Vyacheslav Ryabov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: