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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT07204834
Eligibility Criteria:
Inclusion Criteria:
* Chronic heart failure with reduced ejection fraction, HFrEF, i.e., left ventricular ejection fraction ≤40%, or mildly reduced ejection fraction, HFmrEF, i.e., left ventricular ejection fraction 41-49%, confirmed with an echocardiography showing HFrEF or HFmrEF in the last 6 months and having reached stable medication titration (highest tolerated dose) for ≥1 month
* Functional class New York Heart Association (NYHA) II or III, confirmed by the clinical staff
* Age ≥18 years old
Exclusion Criteria:
* Signs or symptoms of decompensated heart failure in the last month
* Uncontrolled arrhythmia
* Limiting angina (grade III or IV)
* Severe symptomatic aortic stenosis
* Persistent symptomatic hypotension
* In the last 3 months: myocardial infarction, revascularization procedure (i.e., percutaneous coronary intervention, coronary artery bypass graft) or insertion of a cardiac device (e.g., implantable cardioverter defibrillator, bi-ventricular pacemaker)
* Comorbid diagnosed conditions that either contraindicate physical activity or may adversely impact adherence to trial procedures, such as active malignancy, major depression or other significant psychiatric disorders, dementia, or significant hearing or visual impairment
* Inability to walk independently (i.e., requires assistive devices for ambulation)
* Already participates in a clinical trial or plans to participate in other interventions that could affect this trial, such as cardiac rehabilitation, during the study period
* Both the participant and caregiver are unable to access a smartphone or internet, or have null technology literacy (i.e., unable to use WhatsApp or a simple Web page)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07204834
Study Brief:
Protocol Section:
NCT07204834