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:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT06378632
Eligibility Criteria:
Major Inclusion Criteria:
1. Age 22 or greater
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:
1. One ADHF hospitalization in the last 12 months
2. One unplanned IV/SC diuretic administration in the last 6 months
3. Two unplanned IV/SC diuretic administrations in the last 12 months
4. NTProBNP \>500 pg/ml
4. Clinically stable HF according to investigator discretion
5. Willing to participate as evidenced by signing the written informed consent.
Major Exclusion Criteria:
1. Unable to comply with daily use of the App,
2. Has had a major cardiovascular event within 3 months prior to enrolment.
3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
6. Was treated for a significant COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06378632
Study Brief:
Protocol Section:
NCT06378632