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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT07046169
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis:
Hospitalized adults (age 18-90) with acute decompensated HF per ESC 2023 criteria:
Signs/symptoms (e.g., dyspnea, edema) + objective evidence (e.g., elevated NT-proBNP, imaging).
Clinical Status:
NYHA Class II-IV at admission. Systolic BP ≥90 mmHg without vasopressor support.
Technical Feasibility:
Able to undergo POCUS assessments (supine positioning, adequate acoustic windows).
Consent:
Willing to provide informed consent and complete follow-up.
Exclusion Criteria:
* Respiratory Confounders Active pneumonia, interstitial lung disease, or lung cancer (may mimic/obscure B-lines).
COPD with pulmonary hypertension (mPAP ≥25 mmHg) or cor pulmonale (alters IVC dynamics).
Cardiovascular Instability Cardiogenic shock (SBP \<90 mmHg + lactate \>2 mmol/L requiring inotropes). Acute coronary syndrome (STEMI/NSTEMI) within 7 days (may require alternate therapies).
Technical Barriers Subcostal scarring or abdominal dressings preventing IVC visualization. Body habitus (BMI \>40 kg/m²) with persistently poor acoustic windows. Renal/Hepatic Risk AKI (KDIGO Stage 2/3) or dialysis dependence (limits diuretic responsiveness). Cirrhosis (Child-Pugh B/C) (alters volume assessment reliability). Procedural/Logistic Planned cardiac device implantation (e.g., CRT) during hospitalization. Non-adherence (inability to complete follow-up per protocol). Other Exclusions Pregnancy (physiologic IVC changes confound interpretation). Terminal illness (life expectancy \<6 months unrelated to HF).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07046169
Study Brief:
Protocol Section:
NCT07046169