Ischemic Heart Disease Clinical Trial
— FHIDOfficial title:
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 - ?hrombosis 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Institutite for Cardiology | Tomsk | Tomskii region |
Russian Federation | Scientific and Research Institution of Cardiology of Siberian Department of RAMS | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Russian Academy of Medical Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of inflammatory infiltrate in the myocardial tissue | 6 month after PCI or CABG | No | |
Secondary | Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue | 6 month after PCI or CABG | No | |
Secondary | The most frequent viral agents in myocardial tissue in this region | 6 month after PCI or CABG | No | |
Secondary | Incidence of the acute myocardial infarction | 6 and 12 month after PCI or CABG | No | |
Secondary | Incidence of disturbance rhythm and conduction of the heart | 6 and 12 month after PCI or CABG | No | |
Secondary | Left ventricular ejection fraction (Echo) | 6 and 12 month after PCI or CABG | No | |
Secondary | ?nd-diastolic volume of the left ventricle (Echo) | 6 and 12 month after PCI or CABG | No | |
Secondary | ?nd-systolic volume of the left ventricle (Echo) | 6 and 12 month after PCI or CABG | No | |
Secondary | Incidence of the mortality | 6 and 12 month after PCI or CABG | No | |
Secondary | Incidence of the stroke | 6 and 12 month after PCI or CABG | No | |
Secondary | Incidence of hospitalizations for decompensation heart failure | 6 and 12 month after PCI or CABG | No |
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