The purpose of this clinical randomized trial is to evaluate the efficacy and safety of Sacubitril/Valsartan compared with ARB in improving cardiac remodeling in patients With Enlarged Left Atrium Diameter and Persistent AF.
Atrial fibrillation is one of the most common arrhythmia around the word. Prolonged atrial fibrillation may lead to structural changes in the heart such as atrial enlargement, which is an important risk factor for heart failure. Sacubitril/Valsartan is a new drug for the treatment of heart failure, previous studies have shown that it has a good effect in improving cardiac function. For patients with persistent atrial fibrillation and enlarged left atrial, the effect of reversing cardiac remodeling after catheter ablation is unclear. Some studies have described its positive effects in improving cardiac remodeling, but there is still no large-scale randomized controlled trial to further confirm. The investigators hypothesized that Sacubitril/Valsartan can reverse cardiac remodeling in patients with persistent atrial fibrillation and enlarged left atrium compared with ARB after catheter ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
After catheter ablation,during a single blind, run-in period, participants received placebo. Then started with 50 mg LCZ696 for 2-4 weeks, then uptitrated to 100 mg bid for 2-4 weeks, and thereafter, uptitrated to 200 mg bid or tolerable maximum dose ≥6 months.
After catheter ablation,during a single blind, run-in period, participants received placebo. Then started with 40 mg Valsartan daily (qd) for 2-4 weeks, then were uptitrated to 80mg qd or tolerable maximum dose ≥6 months.
Left atrial size changes compared to baseline levels
Echocardiography was used to assess the size of the left atrium, and the changes in atrial structure and baseline levels were compared. The effective index was a gradual decrease in the atrium.
Time frame: 6months and 12 months
Freedom from AF or AT without the use of antiarrhythmic drugs at 12 months after a single ablation procedure.
Confirmation of atrial fibrillation by electrocardiogram or dynamic electrocardiogram during follow-up. Patients with AF or AT that occurred in the first 3 months after the ablation (blanking period) were censored. Each episode that lasted \>30 s was regarded as a recurrence.
Time frame: 12 months
all-cause death
all-cause death
Time frame: 12 months
Time to first documented recurrence of atrial arrhythmias
Time to first documented recurrence of atrial arrhythmias
Time frame: 12 months
Number of hospitalizations caused by heart failure
Number of hospitalizations caused by heart failure
Time frame: 12 months
All-cause hospitalizations
All-cause hospitalizations
Time frame: 12 months
Number of patients requires adjustment of the drug because of Hypotension
Number of patients requires adjustment of the drug because of Hypotension
Time frame: 12 months
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Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction
A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.
Time frame: 12 months
Right atrial size changes compared to baseline levels
Echocardiography was used to assess the size of the right atrium, and the changes in atrial structure and baseline levels were compared. The effective index was a gradual decrease in the atrium.
Time frame: 12 months