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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07419360
Eligibility Criteria:
Inclusion Criteria:
* Adult patients age \>18 years and.
* Clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g., peripheral edema, pleural effusion, or ascites) and
* Assessment of left ventricular ejection fraction (LVEF) by echocardiography performed during the time of index hospitalization or within 3 months prior to enrollment and.
* Radiographic evidence of moderate to large pleural effusion, defined as pleural fluid occupying more than 1/3rd of the hemithorax on chest X-ray.
Exclusion Criteria:
* Clinical indication for diagnostic thoracentesis - Presence of fever, clinical signs of infection, or atypical pleural effusion for CHF (unilateral left-sided effusion, findings suggestive of malignancy, infection, or alternative etiologies) or.
* Loculated pleural effusion - Evidence of loculated pleural effusion on thoracic ultrasound, as defined as the presence of septations or complex homogenous echogenic fluid (see Imaging Assessment section) or.
* Clinical indication for therapeutic thoracentesis - Presence of massive pleural effusion with acute respiratory failure requiring positive pressure ventilation, high-flow oxygen therapy (\>15 liters per minute of flow), or tension hydrothorax (massive effusion with mediastinal shift and hemodynamic compromise) or.
* Contraindication to thoracentesis, uncontrolled bleeding diathesis, or irreversible INR \> 2.0 and platelet count \<50,000 or.
* Patient with mechanical mitral valve, where anticoagulation cannot be safely held or.
* Pleural procedure, such as but not limited to thoracentesis, chest tube placement, or thoracoscopy, within 3 months prior to enrollment or.
* Cardiac or thoracic surgery within 3 months prior to enrollment or.
* Requirement for chronic renal replacement therapy, such as hemodialysis or peritoneal dialysis or.
* Pregnancy or
* Inability or unwillingness to provide informed consent, or current incarceration (prisoners).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07419360
Study Brief:
Protocol Section:
NCT07419360