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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
An invasive procedure performed under local anesthesia. An electroanatomic mapping system (CARTO 3) was used to identify the arrhythmogenic substrate of the PMVT. Radiofrequency energy was delivered via an irrigated-tip catheter (30-35 W, 43°C, 17 mL/min saline irrigation) to ablate the target sites. The procedural endpoint was the non-inducibility of the clinical arrhythmia. Post-procedure, patients were prescribed amiodarone.
Standard medical therapy for heart failure, including spironolactone (20 mg once daily), metoprolol succinate (25 mg twice daily), and sacubitril/valsartan (50 mg twice daily). Doses were titrated according to patient tolerance and clinical guidelines.
The First Hospital of Zhangjiakou City
Zhangjiakou, Hebei, China
Change in Left Ventricular Ejection Fraction (LVEF)
Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function.
Time frame: Baseline, 6 Months Post-treatment
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Measured by CMR to assess cardiac size and remodeling.
Time frame: Baseline, 6 Months Post-treatment
Change in Left Ventricular End-Systolic Volume (LVESV)
Measured by CMR to assess cardiac size and remodeling.
Time frame: Baseline, 6 Months Post-treatment
Change in Stroke Volume (SV)
Measured by CMR as the difference between LVEDV and LVESV.
Time frame: Baseline, 6 Months Post-treatment
Total Clinical Effective Rate
Assessed based on a composite of ECG improvement (including PVC burden reduction) and improvement in New York Heart Association (NYHA) functional class.
Time frame: 6 Months Post-treatment
Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP)
Measured by ELISA as a biomarker for myocardial injury.
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Soluble ST2 (sST2)
Measured by ELISA as a biomarker for myocardial fibrosis and inflammation.
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Galectin-3 (Gal-3)
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Measured by ELISA as a biomarker for myocardial fibrosis.
Time frame: Baseline, 6 Months Post-treatment
Change in Serum Tissue Inhibitor of Metalloproteinase-1 (TIMP-1)
Measured by double-antibody sandwich method as a biomarker related to extracellular matrix regulation.
Time frame: Baseline, 6 Months Post-treatment
Incidence of Adverse Events
Number of participants experiencing any adverse events, including procedural complications, medication side effects, and arrhythmia recurrence.
Time frame: Through study completion, an average of 6 months