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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02523560
Eligibility Criteria:
Inclusion Criteria:
* patients of either sex with any aetiology of left ventricular systolic HF \[as defined in the European Society of Cardiology (ESC) guidelines\]
* with a left ventricular ejection fraction (LVEF) ≤40% on echocardiography;
* in New York Heart Association (NYHA) class I, II or III;
* who are to have had a hospitalization incident, be stable clinically (a patient does not need intravenous medication or has not had therapy modified for at least 7 days);
* who has no contraindications to undergo cardiopulmonary exercise test and
* who are able to exercise using the new model of home-based telerehabilitation.
Exclusion Criteria:
* NYHA class IV;
* unstable angina;
* unstable clinical status
* a history of acute coronary syndrome within the last forty days in patients with LVEF ≤35%; percutaneous angioplasty (PCI) within the last 2 weeks, coronary artery bypass grafting within the last 3 months, or initiation of cardiac resynchronization therapy (CRT-P, CRT-D) and/or implantable cardioverter-defibrillator (ICD) or pacemaker within the last six weeks;
* lack of ICD, CRT-P or CRT-D therapy despite the indications for implantation according to ESC guidelines;
* intracardiac thrombus
* rest heart rate (HR) \>90/min,
* tachypnoea \>20 breaths per minute
* symptomatic and/or exercise-induced cardiac arrhythmia or conduction disturbances;
* acute myocarditis and/or pericarditis
* valvular or congenital heart disease requiring surgical treatment;
* hypertrophic cardiomyopathy;
* severe pulmonary disease;
* uncontrolled hypertension;
* anemia (haemoglobin \<11.0 g/dL);
* physical disability related to severe musculoskeletal or neurological problems;
* recent embolism;
* thrombophlebitis;
* acute or chronic inflammatory disease;
* acute or chronic decompensated non-cardiac diseases (thyreotoxicosis, uncontrolled diabetes)
* active malignant neoplastic diseases with survival prognosis below 2 - 5 years;
* orthotropic heart transplant in anamnesis;
* aortic aneurysm;
* severe psychiatric disorder; and
* patient's refusal to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02523560
Study Brief:
Protocol Section:
NCT02523560