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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04062760
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female patient, 18 years or older
* Patients admitted to Cardiology or Internal Medicine units with a diagnosis of acute decompensated heart failure and congestion: NT-proBNP \> 1,000 pg/ml or BNP \>250 pg/ml, dyspnea and at least two of the following clinical signs: 2+ pitting edema, pulmonary edema/pleural effusions at chest x-ray or US body weight increase above usual \> 5% over the last 4 weeks
* Clinically stable patients that can be switched to oral diuretic therapy after 24-72 hours of an algorithm-based treatment with high-dose intravenous furosemide started at the time of hospital admission
* Patients capable to provide written informed consent
Exclusion Criteria:
* Serum creatinine levels \> 3.5 mg per deciliter at admission to the hospital or usual estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73 m2 by the MDRD or CKD-EPI formula
* Systolic blood pressure \< 90 mmHg at time of enrollment and/or hemodynamic instability severe enough to require intravenous inotropes, intravenous vasodilators, or both
* Severe arrhythmias with hemodynamic instability or DC shock occurred prior to randomization
* Ascertained acute coronary syndrome (ACS), or ACS occurred within the last 4 weeks
* Hematocrit \> 45%
* Use of iodinated radio contrast material occurred in the last 72 hours
* Current mechanical ventilator support
* Previous solid organ transplant
* Primary hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or cardiac tamponade, severe valvular stenosis
* Complex congenital heart disease
* Liver disease (serum ALT or AST \> 4, and/or total serum bilirubin \> 3)
* Known bilateral renal artery stenosis
* Active sepsis or ongoing systemic infection
* Active gastrointestinal tract bleeding
* Enrollment in another clinical trial
* Locally advanced or metastatic cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04062760
Study Brief:
Protocol Section:
NCT04062760