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| Name | Class |
|---|---|
| The First Hospital of Zhangjiakou City | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Radiofrequency Catheter Ablation (RFCA) Group | Experimental | 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. |
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| Active Comparator: Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Catheter Ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | Measured by Cardiac Magnetic Resonance (CMR) imaging to assess global systolic function. | Baseline, 6 Months Post-treatment |
| Change in Left Ventricular End-Diastolic Volume (LVEDV) | Measured by CMR to assess cardiac size and remodeling. | Baseline, 6 Months Post-treatment |
| Change in Left Ventricular End-Systolic Volume (LVESV) | Measured by CMR to assess cardiac size and remodeling. | Baseline, 6 Months Post-treatment |
| Change in Stroke Volume (SV) | Measured by CMR as the difference between LVEDV and LVESV. | Baseline, 6 Months Post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months Post-treatment |
| Change in Serum Heart-type Fatty Acid-Binding Protein (H-FABP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Zhangjiakou City | Zhangjiakou | Hebei | 075100 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Guideline-Directed Medical Therapy (GDMT) | Drug | 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. |
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Measured by ELISA as a biomarker for myocardial injury. |
| Baseline, 6 Months Post-treatment |
| Change in Serum Soluble ST2 (sST2) | Measured by ELISA as a biomarker for myocardial fibrosis and inflammation. | Baseline, 6 Months Post-treatment |
| Change in Serum Galectin-3 (Gal-3) | Measured by ELISA as a biomarker for myocardial fibrosis. | 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. | 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. | Through study completion, an average of 6 months |
| D013514 |
| Surgical Procedures, Operative |