Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction (FHID)
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tomsk, Fédération Russe, 634012
- Recrutement
- Scientific and Research Institution of Cardiology of Siberian Department of RAMS
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Chercheur principal:
- Vyacheslav Ryabov, MD, PhD
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Contact:
- Vyacheslav Ryabov, MD, Phd
- Numéro de téléphone: +73822553689
- E-mail: rvvt@cardio.tsu.ru
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Tomskii region
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Tomsk, Tomskii region, Fédération Russe, 634012
- Recrutement
- Research Institutite for Cardiology
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Contact:
- Vyacheslav Ryabov, MD, Phd
- Numéro de téléphone: +73822553689
- E-mail: rvvt@cardio-tomsk.ru
-
Chercheur principal:
- Vyacheslav Ryabov, MD, PhD
-
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: chronic inflammation
All patients will be held PCI to exclude ischemic heart failure decompensation.
Also, all patients will be performed endomyocardial biopsy.
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Incidence of inflammatory infiltrate in the myocardial tissue
Délai: 6 month after PCI or CABG
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6 month after PCI or CABG
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
Délai: 6 month after PCI or CABG
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6 month after PCI or CABG
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The most frequent viral agents in myocardial tissue in this region
Délai: 6 month after PCI or CABG
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6 month after PCI or CABG
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Incidence of the acute myocardial infarction
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of disturbance rhythm and conduction of the heart
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Left ventricular ejection fraction (Echo)
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Еnd-diastolic volume of the left ventricle (Echo)
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Еnd-systolic volume of the left ventricle (Echo)
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of the mortality
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of the stroke
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Incidence of hospitalizations for decompensation heart failure
Délai: 6 and 12 month after PCI or CABG
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6 and 12 month after PCI or CABG
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Vyacheslav Ryabov, MD, PhD, Research Institute for Cardiology
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1801
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