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A Prospective, Multicenter Cohort Study on Guideline-Directed Medical Therapy for Heart Failure with Reduced Ejection Fraction in Chinese Children: Application and Efficacy

A Prospective, Multicenter Cohort Study on Guideline-Directed Medical Therapy for Heart Failure with Reduced Ejection Fraction in Chinese Children: Application and Efficacy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119385
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Observation Group:none

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

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

MeasureTime 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

MeasureTime 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

Public ContactJie Tian

Children's Hospital of Chongqing Medical University

jieetian@cqmu.edu.cn+86 23 6363 3496

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026