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

NCT ID: NCT02649517

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-10-31

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.

Conditions

Decompensated Heart Failure; Ischemic Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

chronic inflammation

All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy.

Group Type: OTHER

Endomyocardial biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

EMB

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Vyacheslav Ryabov

MD,PhD Research Institute for Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vyacheslav Ryabov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Cardiology

Locations

Research Institutite for Cardiology

Tomsk, Tomskii Region, Russia

Site Status: RECRUITING

Scientific and Research Institution of Cardiology of Siberian Department of RAMS

Tomsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Vyacheslav Ryabov, MD, PhD

Role: CONTACT

rvvt@cardio-tomsk.ru

+73822553689

Ekaterina Krychinkina, MD

Role: CONTACT

katy990@mail.ru

+73822558360

Facility Contacts

Vyacheslav Ryabov, MD, Phd

Role: primary

rvvt@cardio-tomsk.ru

+73822553689

Vyacheslav Ryabov, MD, Phd

Role: primary

rvvt@cardio.tsu.ru

+73822553689

Other Identifiers

1801

Identifier Type: -

Identifier Source: org_study_id