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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT04405804
Eligibility Criteria:
Inclusion Criteria:
* Dilated cardiomyopathy defined according to the indications of the Cardiomyopathy Task Force (dilation \> 2 Standard Deviations (SD) and hypokinesia);
* Class NYHA/Ross ≥ II;
* Ejection fraction \< 40%;
* Patients with acute heart failure episodes (both new episode and relapse) in the last three months;
* Systolic blood pressure \> 50° age and height;
* Heart rate: 6-12 months: ≥105 bpm, \>1 year \<3 years: ≥95 bpm, 3-5 years: ≥75 bpm, 5-18 years: \>70 bpm.
Exclusion Criteria:
* Cardiogenic shock in the three months;
* Hypertrophic, restrictive or mixed cardiomyopathy;
* Acute lymphocytic myocarditis diagnosed with endomyocardial biopsy;
* Significant Valvular Pathology;
* Sinus block and congenital long QT syndrome;
* Atrial Fibrillation;
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \> 2.5 times normal, bilirubin \> 3 and creatinine \> 2.5 mg/dL;
* Pregnancy and/or positive pregnancy test patients;
* Hypersensitivity to the active substance or any of the excipients;
* Participation in a clinical trial in which an experimental drug was administered within 30 days or 5 half-lives of the investigational drug;
* Chronic lung disease or other clinical condition that the investigating physician believes is incompatible with the study;
* eGFR \<15 mL/min/1.73 m2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT04405804
Study Brief:
Protocol Section:
NCT04405804