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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT06921603
Eligibility Criteria:
List the inclusion criteria:
1. Age: Patients must be 18 years or older.
2. Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
3. Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
4. POCUS Measurement: Must have an abnormal right internal jugular vein (RIJV) distensibility index (DI) of \<66% on point-of-care ultrasound (POCUS) at the time of admission.
These criteria ensure that participants are appropriately selected for the study and are likely to benefit from POCUS-guided diuretic management.
List the exclusion criteria:
1. Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
2. Anatomical Incompatibilities: Excludes patients with RIJV or superior vena cava thrombus, congenital heart disease, or severe tricuspid regurgitation, as these conditions may impair accurate POCUS measurements.
3. Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
4. End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
5. Advanced Cancer: Patients with metastatic cancer will be excluded.
6. Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
7. End stage chronic kidney disease
8. Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
9. Inotropic Support: Patients requiring inotropic support at the time of enrollment will be excluded, as they represent a more severe heart failure profile that may not be suitable for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06921603
Study Brief:
Protocol Section:
NCT06921603