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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04698005
Eligibility Criteria:
Inclusion Criteria:
* Chronic heart failure due ischemic or nonischemic cardiomyopathy
* Acute decompensation of heart failure with the need of inotropes
* Achievement of relative stabilization on inotropes (INTERMACS class \>2)
* Left ventricular ejection fraction \<= 35%
* Age \>18 years
Exclusion Criteria:
* Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours
* Chronic kidney disease grade 4 or 5
* Diabetic ketoacidosis (3-OHB \>2mmol/l at baseline)
* Hemodynamic severe arrhythmias
* Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)
* Contraindications to invasive hemodynamic monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04698005
Study Brief:
Protocol Section:
NCT04698005