Heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pediatric patients under 18 years of age with chronic heart failure, diagnosed according to the 2025 International Society for Heart and Lung Transplantation (ISHLT) Guidelines for Pediatric Heart Failure and the 2020 Chinese Recommendations for the Diagnosis and Management of Pediatric Heart Failure. 2. Presence of left ventricular systolic dysfunction (LVEF <50%) confirmed by echocardiography, and scheduled to initiate Guideline-Directed Medical Therapy (GDMT). 3. Ability to adhere to regular follow-up visits at the participating clinical site for at least one year post-enrollment. 4. Written informed consent provided by the patient and/or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 3 months, or planned cardiac transplantation within 3 months. 2. Comorbid conditions that would significantly compromise follow-up adherence or data quality (e.g., active malignancy, severe neurological disability precluding cooperation). 3. Known allergy or contraindication to GDMT medications (e.g., severe hepatic or renal dysfunction). 4. Any other condition which, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children achieving target or maximally tolerated doses of guideline-directed medical therapy (GDMT) at 12 months after enrollment, stratified by GDMT class and combination level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cardiac function and remodeling parameters over time, including: NYHA/ROSS functional class, Echocardiographic parameters , Biomarker.;Incidence of composite clinical endpoints;Incidence of adverse drug reactions related to GDMT; Incidence and reasons for dose reduction or permanent discontinuation of GDMT due to safety concerns.;Time from enrollment to first initiation of each GDMT drug class; Time from enrollment to first achievement of combination therapy with 2, 3, or 4 GDMT drug classes.; | — |
Countries
China
Contacts
Children's Hospital of Chongqing Medical University