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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT04999995
Eligibility Criteria:
Inclusion Criteria:
* Admission for decompensated HF (traditional diagnostic criteria will be utilized for diagnosing ADHF - presence of dyspnea as presenting complaint; evidence of volume overload - peripheral or pulmonary edema, elevated jugular venous pressure \> 10 cmH2O, presence of hepatojugular reflux, or ascites; elevated B-type Natriuretic Peptide (\>100ng/ml); evidence of pulmonary vascular congestion on chest x-ray1, or Admission for dyspnea that is NOT related to ADHF (absence of all HF symptoms and signs mentioned in ADHF inclusion criteria- except for dyspnea as presenting complaint)
* Able to give informed consent
* Age \>= 18 years
Exclusion Criteria:
* Mortality during inpatient observation
* Presence of acute stroke (ischemic or hemorrhagic)
* Presence of intracranial hemorrhage
* History of acute stroke (ischemic or hemorrhagic) or intracranial hemorrhage within the preceding 6 months
* Presence of decompensated liver disease (elevated ALT/AST; ascites; Acute variceal bleeding; or hepatic encephalopathy)
* Presence of sepsis
* Presence of severe hyponatremia (Serum sodium \< 130 meq/L)
* Active malignancy (undergoing chemotherapy, radiation therapy, or planned surgical intervention)
* SARS-CoV-2 positive during the current admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04999995
Study Brief:
Protocol Section:
NCT04999995