Efficacy of Radiofrequency Catheter Ablation on Improving Cardiac Function in Patients With Polymorphic Ventricular Tachycardia and Coexisting Heart Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
This is a prospective, randomized, controlled trial to investigate the efficacy of radiofrequency catheter ablation (RFCA) combined with guideline-directed medical therapy (GDMT) compared to GDMT alone in patients with polymorphic ventricular tachycardia (PMVT) and coexisting heart failure (HF). The study aims to evaluate whether the addition of RFCA can lead to superior improvements in cardiac function, clinical outcomes, and serum biomarkers at a 6-month follow-up.
详细描述
The co-occurrence of polymorphic ventricular tachycardia (PMVT) and heart failure (HF) presents a significant clinical challenge with poor prognosis. While guideline-directed medical therapy (GDMT) is standard care, it may not adequately address the arrhythmic substrate. Radiofrequency catheter ablation (RFCA) has proven effective for other arrhythmias in the context of HF, but its role in PMVT is less established. This study tests the hypothesis that RFCA, as an adjunct to GDMT, is superior to GDMT alone in this high-risk population. A total of 118 eligible patients with PMVT and HF were randomized in a 1:1 ratio to receive either RFCA plus GDMT (Study Group) or GDMT alone (Control Group). The primary objective is to compare changes in cardiac function parameters (LVEF, LVEDV, LVESV, SV) assessed by Cardiac Magnetic Resonance (CMR) from baseline to 6 months post-treatment. Secondary objectives include evaluating differences in clinical efficacy, serum biomarkers of myocardial injury and fibrosis (H-FABP, sST2, Gal-3, TIMP-1), and the incidence of adverse events between the two groups. The findings aim to provide robust evidence for RFCA as a therapeutic strategy to improve cardiac function and clinical outcomes for patients with PMVT and HF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of polymorphic ventricular tachycardia (PMVT) and coexisting heart failure (HF) via ECG and clinical evaluation.
- •New York Heart Association (NYHA) functional class II-IV.
- •First-time candidate for RFCA.
- •Provided written informed consent.
排除标准
- •Diagnosis of a malignant tumor.
- •Severe psychiatric disorders.
- •History of thyroid diseases or collagen diseases.
- •Recent infectious diseases.
- •Severe dysfunction of the lungs, liver, or kidneys.
- •Coexisting coagulation disorders.
- •Contraindications to amiodarone.
- •Pregnancy or lactation.
- •Congenital heart disease, cor pulmonale, or other primary structural heart diseases.
- •Prior pacemaker implantation.
- •Cardiac surgery within the previous 3 months.
研究组 & 干预措施
Experimental: Radiofrequency Catheter Ablation (RFCA) Group
Patients received Radiofrequency Catheter Ablation (RFCA) in addition to standard Guideline-Directed Medical Therapy (GDMT). GDMT included spironolactone 20 mg/day, metoprolol succinate 25 mg twice daily, and sacubitril/valsartan 50 mg twice daily, titrated as tolerated. Patients were followed for 6 months post-procedure.
干预措施: Guideline-Directed Medical Therapy (GDMT) (Drug)
Active Comparator: Control Group
Patients received standard Guideline-Directed Medical Therapy (GDMT) alone. The regimen included spironolactone 20 mg/day, metoprolol succinate 25 mg twice daily, and sacubitril/valsartan 50 mg twice daily, titrated as tolerated. Patients were followed for 6 months.
干预措施: Guideline-Directed Medical Therapy (GDMT) (Drug)
Experimental: Radiofrequency Catheter Ablation (RFCA) Group
Patients received Radiofrequency Catheter Ablation (RFCA) in addition to standard Guideline-Directed Medical Therapy (GDMT). GDMT included spironolactone 20 mg/day, metoprolol succinate 25 mg twice daily, and sacubitril/valsartan 50 mg twice daily, titrated as tolerated. Patients were followed for 6 months post-procedure.
干预措施: Radiofrequency Catheter Ablation (Device)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: Baseline, 6 Months Post-treatment
Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function.
Change in Left Ventricular End-Diastolic Volume (LVEDV)
时间窗: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Change in Left Ventricular End-Systolic Volume (LVESV)
时间窗: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Change in Stroke Volume (SV)
时间窗: Baseline, 6 Months Post-treatment
Measured by CMR as the difference between LVEDV and LVESV.
次要结局
- Total Clinical Effective Rate(6 Months Post-treatment)
- Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP)(Baseline, 6 Months Post-treatment)
- Change in Serum Soluble ST2 (sST2)(Baseline, 6 Months Post-treatment)
- Change in Serum Galectin-3 (Gal-3)(Baseline, 6 Months Post-treatment)
- Change in Serum Tissue Inhibitor of Metalloproteinase-1 (TIMP-1)(Baseline, 6 Months Post-treatment)
- Incidence of Adverse Events(Through study completion, an average of 6 months)
研究者
Qian Feng
Principal investigator
The Second Affiliated Hospital of Hebei North University