The First Hospital of Zhangjiakou City
Zhangjiakou, Hebei, 075100, China
NCT Number: NCT07130175
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zhangjiakou, Hebei, 075100, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 6 Months Post-treatment
Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function.
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR to assess cardiac size and remodeling.
Time frame: Baseline, 6 Months Post-treatment
Measured by CMR as the difference between LVEDV and LVESV.
Time frame: 6 Months Post-treatment
Assessed based on a composite of ECG improvement (including PVC burden reduction) and improvement in New York Heart Association (NYHA) functional class.
Time frame: Baseline, 6 Months Post-treatment
Measured by ELISA as a biomarker for myocardial injury.
Time frame: Baseline, 6 Months Post-treatment
Measured by ELISA as a biomarker for myocardial fibrosis and inflammation.
Time frame: Baseline, 6 Months Post-treatment
Measured by ELISA as a biomarker for myocardial fibrosis.
Time frame: Baseline, 6 Months Post-treatment
Measured by double-antibody sandwich method as a biomarker related to extracellular matrix regulation.
Time frame: Through study completion, an average of 6 months
Number of participants experiencing any adverse events, including procedural complications, medication side effects, and arrhythmia recurrence.
Qian Feng
Other
Efficacy of Radiofrequency Catheter Ablation on Improving Cardiac Function in Patients With Polymorphic Ventricular Tachycardia and Coexisting Heart Failure: A Randomized Controlled Trial
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