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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT01112150
Eligibility Criteria:
Inclusion Criteria:
* hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
* documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (\> 35 mmHg) is expected in such cases.
Exclusion Criteria:
* patients in sepsis,
* hemodynamically unstable,
* during an acute attack of pulmonary edema,
* with renal failure (creatinine \> 2 mg%),
* with DVT,
* psychiatric or noncompliant patients, and
* patients who will not sign the informed consent form will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01112150
Study Brief:
Protocol Section:
NCT01112150