Decompensated Heart FailureFHIDNCT02649517
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction
A study testing Endomyocardial biopsy in people with Decompensated Heart Failure and Ischemic Heart Disease, run by Russian Academy of Medical Sciences at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Heart Failure, Ischemic Heart Disease
- What is being tested?
- Endomyocardial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- Jan 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Research Institutite for Cardiology
Tomsk, Tomskii Region, 634012
Vyacheslav Ryabov, MD, Phd, +73822553689, rvvt@cardio-tomsk.ru
Vyacheslav Ryabov, MD, PhD
- Recruiting
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Tomsk, 634012
Vyacheslav Ryabov, MD, Phd, +73822553689, rvvt@cardio.tsu.ru
Vyacheslav Ryabov, MD, PhD
About this study
Official 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.
Read the 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.
- Being tested
- Endomyocardial biopsy
- Keywords
- decompensated heart failure, ischemic heart disease, inflammatory cardiomyopathy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomyocardial biopsyProcedure or surgery
Also called EMB
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic inflammation | Other | All patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy. Receives: Procedure: Endomyocardial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inflammatory infiltrate in the myocardial tissue
Measured: 6 month after PCI or CABG
Secondary outcomes (10)
Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
Measured: 6 month after PCI or CABG
The most frequent viral agents in myocardial tissue in this region
Measured: 6 month after PCI or CABG
Incidence of the acute myocardial infarction
Measured: 6 and 12 month after PCI or CABG
Incidence of disturbance rhythm and conduction of the heart
Measured: 6 and 12 month after PCI or CABG
Left ventricular ejection fraction (Echo)
Measured: 6 and 12 month after PCI or CABG
Еnd-diastolic volume of the left ventricle (Echo)
Measured: 6 and 12 month after PCI or CABG
Еnd-systolic volume of the left ventricle (Echo)
Measured: 6 and 12 month after PCI or CABG
Incidence of the mortality
Measured: 6 and 12 month after PCI or CABG
Incidence of the stroke
Measured: 6 and 12 month after PCI or CABG
Incidence of hospitalizations for decompensation heart failure
Measured: 6 and 12 month after PCI or CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vyacheslav Ryabov, Russian Academy of Medical Sciences
- Investigators
- Vyacheslav Ryabov, MD, PhD, Principal investigator, Research Institute for Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649517
- Sponsor's protocol ID
- 1801
- Acronym
- FHID
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated Heart Failure With Ischemic Systolic Dysfunction
- ClinicalTrials.gov ID
- NCT02649517
- Acronym / sponsor ID
- FHID / 1801
- Keywords
- decompensated heart failure, ischemic heart disease, inflammatory cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic inflammation | Other | Procedure: Endomyocardial biopsyAll patients will be held PCI to exclude ischemic heart failure decompensation. Also, all patients will be performed endomyocardial biopsy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endomyocardial biopsyAlso: EMBEndomyocardial 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. | Procedure or surgery | chronic inflammation |
Primary outcome
Incidence of inflammatory infiltrate in the myocardial tissue
Time frame: 6 month after PCI or CABG
10 secondary outcomes
Incidence of the virus - positive inflammatory infiltrate in the myocardial tissue
Time frame: 6 month after PCI or CABG
The most frequent viral agents in myocardial tissue in this region
Time frame: 6 month after PCI or CABG
Incidence of the acute myocardial infarction
Time frame: 6 and 12 month after PCI or CABG
Incidence of disturbance rhythm and conduction of the heart
Time frame: 6 and 12 month after PCI or CABG
Left ventricular ejection fraction (Echo)
Time frame: 6 and 12 month after PCI or CABG
Еnd-diastolic volume of the left ventricle (Echo)
Time frame: 6 and 12 month after PCI or CABG
Еnd-systolic volume of the left ventricle (Echo)
Time frame: 6 and 12 month after PCI or CABG
Incidence of the mortality
Time frame: 6 and 12 month after PCI or CABG
Incidence of the stroke
Time frame: 6 and 12 month after PCI or CABG
Incidence of hospitalizations for decompensation heart failure
Time frame: 6 and 12 month after PCI or CABG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vyacheslav Ryabov, MD, PhD principal investigator
Research Institute for Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomyocardial biopsy in people with Decompensated Heart Failure and Ischemic Heart Disease, run by Russian Academy of Medical Sciences at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vyacheslav Ryabov, MD, PhD (+73822553689, rvvt@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inflammatory infiltrate in the myocardial tissue (time frame: 6 month after PCI or CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.