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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04572867
Eligibility Criteria:
Inclusion Criteria:
Subjects must be 18 years of age or older already on standard of care therapy including Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin
Receptor Blockers (ARBs), Sacubitril/Valsartan, beta-blocker, oral diuretic (80 mg Lasix/2 mg Bumex/40 mg Torsemide+/-Thiazide diuretic), and meet the following inclusion criteria to be enrolled:
Inclusion Criteria:
1. CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide)
2. Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the following:
1. Elevated BNP (\>100)
2. Paroxysmal nocturnal dyspnea or orthopnea
3. Elevated jugular venous distention (\>/ 7 cm)
4. X-ray findings consisted with CHF
5. Presence of ascites or LE edema . -
Exclusion Criteria:
1. Acute Coronary Syndrome
2. Hypertensive urgency or emergency
3. Rapid atrial fibrillation difficult to control
4. Contraindication to anticoagulation
5. Pregnancy
6. Requires hemodialysis (\> CR \> 3.0 mg/dl)
7. Symptomatic hypotension
8. Poor venous access
9. Pressor dependent. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04572867
Study Brief:
Protocol Section:
NCT04572867