Study of Drug Therapy for Pediatric Heart Failure

Recruiting

• Conditions: Heart Failure Congenital
• Interventions: Drug: Captopril Tablets; Drug: Potassium citrate powder; Drug: Metoprolol Oral Tablet; Drug: Spironolactone Tablets; Drug: Torsemide Tablets

• Registration Number: NCT06039540
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients.

The main questions it aims to answer are:

* Can a modified drug therapy improve left ventricular function in pediatric heart failure patients?

* Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-09
• Study First Submitted QC: 2023-09-09
• Last Update Submitted: 2023-09-09
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-06-22
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients younger than 14 years of age
• heart failure after congenital heart surgery
• Ross > 2 or NYHA > 2
• LVEF<55%, or LVFS<25%

Exclusion Criteria

• single ventricle
• congenital heart disease without anatomical correction
• Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
• Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
• Patients with severe liver and kidney failure
• Patients who are allergic to related medications
• Patients with symptomatic hypotension who cannot tolerate related drugs
• Refuse to sign the informed consent or refuse to participate in this experiment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional Drug Therapy Group	Potassium citrate powder	Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).
Modified Drug Therapy Group	Torsemide Tablets	Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group
Modified Drug Therapy Group	Metoprolol Oral Tablet	Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group
Modified Drug Therapy Group	Spironolactone Tablets	Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group
Modified Drug Therapy Group	Captopril Tablets	Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group
Modified Drug Therapy Group	Potassium citrate powder	Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group
Traditional Drug Therapy Group	Torsemide Tablets	Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).

Primary Outcome Measures

Name	Time	Method
the recurrence rate of heart failure	after 6 months of treatment	During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of drug adverse reactions	after 6 months of treatment	The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Readmission rate for heart failure	after 6 months of treatment	During follow-up visits, readmission for heart failure will be recorded.
NT-proBNP level	after 6 months of treatment	The trend in NT-proBNP levels.

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China