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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06993220
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Patients hospitalized for new onset heart failure or worsening heart failure defined by:
1. Symptoms classified as New York Heart Association class III or IV.
2. Clinical or instrumental signs of volume overload (e.g., dyspnea with evidence of pulmonary congestion on X-rays or lung ultrasound, pitting edema, and jugular venous distension).
3. Elevated NT-proBNP levels within the first 24 hours of admission (cutoff values: 450 ng/L for patients \< 50 years; \>900 ng/L for patients aged 50-75 years; \>1800 ng/L for patients \>75 years).
* Ability to provide informed consent.
Exclusion Criteria:
* Known diagnosis of septicemia.
* Glomerular filtration rate \< 15 ml/min.
* Life expectancy \< 6 months.
* Active myocarditis.
* Heart transplant recipients.
* Patients with ventricular assist devices.
* Congenital heart diseases.
* Moderate-to-severe liver disease (Child-Pugh B-C).
* Patients that will not be followed up by the Heart Failure Unit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06993220
Study Brief:
Protocol Section:
NCT06993220