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EArly adminiStration of Ivabradine in CHILDren with heart failure
EU CTIS ID: 2025-520916-32-00
What this study is testing
To evaluate the response to ivabradine administration in terms of a reduction in heart rate between 20 and 30% from baseline V1 to ivabradine administration on heart rate after 14 days of stable therapy (V3).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 3 years of age and under 18 years of age and weight ≥ 25 kg; Dilated cardiomyopathy defined according to the indications of the Cardiomyopathy Task Force (dilation > 2 SD and hypokinesia); NYHA/Ross Classification ≥ II; Ejection fraction < 40%; Patients with episode of acute heart failure (both de novo and relapse) in the last three months; Systolic blood pressure > 50th percentile per age and height; Heart rate: 3-5 years ≥75 bpm; 5-18 years >70 bpm; Signed Informed Consent Form (ICF)/Assent by the subject
You likely can't join if
- Hypertrophic, restrictive or mixed cardiomyopathy; Acute lymphocytic myocarditis diagnosed by endomyocardial biopsy; Significant Valvular Pathology; Sinoatrial block and congenital long QT-syndrome; Atrial fibrillation; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 2.5 times above the normal values, bilirubin > 3mg/dL and creatinine > 2.5 mg/dL. Patients who are pregnant and/or have a positive pregnancy test • Hypersensitivity to the active substance or to any of the excipients. • Participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug.
- Chronic lung disease or other clinical condition that, in the opinion of the investigator, is incompatible with the study.eGFR <15 mL/min/1.73 m2 Inability to swallow tablets.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.