Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction (FHID)
Primary Purpose
Decompensated Heart Failure, Ischemic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Endomyocardial biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Decompensated Heart Failure focused on measuring decompensated heart failure, ischemic heart disease, inflammatory cardiomyopathy
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
Sites / Locations
- Research Institutite for CardiologyRecruiting
- Scientific and Research Institution of Cardiology of Siberian Department of RAMSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
chronic inflammation
Arm Description
All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy.
Outcomes
Primary Outcome Measures
Incidence of inflammatory infiltrate in the myocardial tissue
Secondary Outcome Measures
Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
The most frequent viral agents in myocardial tissue in this region
Incidence of the acute myocardial infarction
Incidence of disturbance rhythm and conduction of the heart
Left ventricular ejection fraction (Echo)
Еnd-diastolic volume of the left ventricle (Echo)
Еnd-systolic volume of the left ventricle (Echo)
Incidence of the mortality
Incidence of the stroke
Incidence of hospitalizations for decompensation heart failure
Full Information
NCT ID
NCT02649517
First Posted
January 4, 2016
Last Updated
January 5, 2016
Sponsor
Russian Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02649517
Brief Title
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction
Acronym
FHID
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Heart Failure, Ischemic Heart Disease
Keywords
decompensated heart failure, ischemic heart disease, inflammatory cardiomyopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic inflammation
Arm Type
Other
Arm Description
All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy.
Intervention Type
Procedure
Intervention Name(s)
Endomyocardial biopsy
Other Intervention Name(s)
EMB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of inflammatory infiltrate in the myocardial tissue
Time Frame
6 month after PCI or CABG
Secondary Outcome Measure Information:
Title
Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
Time Frame
6 month after PCI or CABG
Title
The most frequent viral agents in myocardial tissue in this region
Time Frame
6 month after PCI or CABG
Title
Incidence of the acute myocardial infarction
Time Frame
6 and 12 month after PCI or CABG
Title
Incidence of disturbance rhythm and conduction of the heart
Time Frame
6 and 12 month after PCI or CABG
Title
Left ventricular ejection fraction (Echo)
Time Frame
6 and 12 month after PCI or CABG
Title
Еnd-diastolic volume of the left ventricle (Echo)
Time Frame
6 and 12 month after PCI or CABG
Title
Еnd-systolic volume of the left ventricle (Echo)
Time Frame
6 and 12 month after PCI or CABG
Title
Incidence of the mortality
Time Frame
6 and 12 month after PCI or CABG
Title
Incidence of the stroke
Time Frame
6 and 12 month after PCI or CABG
Title
Incidence of hospitalizations for decompensation heart failure
Time Frame
6 and 12 month after PCI or CABG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vyacheslav Ryabov, MD, PhD
Phone
+73822553689
Email
rvvt@cardio-tomsk.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterina Krychinkina, MD
Phone
+73822558360
Email
katy990@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD
Organizational Affiliation
Research Institute for Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institutite for Cardiology
City
Tomsk
State/Province
Tomskii region
ZIP/Postal Code
634012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, Phd
Phone
+73822553689
Email
rvvt@cardio-tomsk.ru
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD
Facility Name
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, Phd
Phone
+73822553689
Email
rvvt@cardio.tsu.ru
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction
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