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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05467735
Eligibility Criteria:
Inclusion Criteria:
1. Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity pitting edema.
2. Patients who are not yet recruited for other pharmacological or medical device clinical trials.
Exclusion Criteria:
1. Age \<18 years.
2. Patient on hemodialysis or peritoneal dialysis.
3. Simultaneous participation in another interventional study.
4. Impossibility to perform lower extremity compression, caused by pathology in either or both lower limbs (e.g. amputation, chronic wounds).
5. No written informed consent.
6. Patient who are on invasive or non-invasive positive pressure ventilation (including BiPAP) or who are requiring \>15L of oxygen.
7. Cardiogenic shock requiring catecholamine infusion.
8. Systolic blood pressure \<80 mmHg.
9. Patients requiring mechanical circulatory support including intra-aortic balloon counter-pulsation or impella.
10. Patients on VAD (Ventricular Assist Device).
11. Severe peripheral artery disease
12. Diagnosis of lower extremity deep venous thrombosis or pulmonary embolism in the last 3 months
13. Expected impossibility to obtain follow-up data at 12-week follow-up.
14. Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05467735
Study Brief:
Protocol Section:
NCT05467735