Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT03726905
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 years and older (inclusive)
* Patients with stable heart failure of the II-III functional class.
* Signed patient informed consent to participate in the study.
* Left ventricular ejection fraction ≤40%, confirmed by the results of EchoCG no more than 3 months before the start of the study.
* Patients who can understand the objectives of this study and comply with the requirements of the Protocol.
Exclusion Criteria:
* • Heart failure I and VI functional class
* Left ventricular ejection fraction\> 41% or no confirmed data on the left ventricular EF.
* Myocardial infarction, ACS, heart surgery, percutaneous coronary intervention, or coronary artery bypass surgery performed less than 3 months prior to randomization.
* Unstable or refractory angina.
* Pulmonary heart.
* Constrictive pericarditis.
* Hypertrophic cardiomyopathy.
* Amyloid cardiomyopathy.
* Syndrome of premature excitation of the ventricles.
* The need for percutaneous coronary intervention or coronary bypass surgery in the near future.
* Sinus node dysfunction syndrome.
* The presence of a pacemaker.
* The presence of diagnosed non-cardiac causes of CHF.
* Any non-cardiac disease that reduces the expected duration to less than 2 years from the moment of randomization.
* A stroke less than 1 month prior to randomization or a stroke with marked continuing neurological disorders less than 12 months before randomization
* Orthopedic disorders that prevent physical training
* COPD, Bronchial asthma. Another lung disease that can affect CSTP results
* Significant impaired renal function (plasma creatinine 220 µmol / L or higher).
* Significant abnormal liver function (increased ALT or AST more than 3 times relative to the upper limit of normal).
* Acute coronary syndrome less than 3 months before randomization.
* Obstructive or restrictive cardiomyopathy.
* Acute myocarditis.
* Hemodynamically significant organic lesions of valves requiring surgical intervention.
* A history of heart transplantation or current waiting for a heart transplant.
* Drug addiction, substance abuse, alcoholism, drug use in history.
* Mental, physical and other reasons that do not allow to adequately assess their behavior and correctly fulfill the conditions of the study protocol.
* A history of any significant, in the opinion of the physician-researcher, condition / disease or circumstances that prevent the inclusion in the study.
* Inability / reluctance of the patient to provide signed informed consent to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03726905
Study Brief:
Protocol Section:
NCT03726905