Efficacy and Safety of ARNI in Reversing Cardiac Remodeling After Catheter Ablation for Patient With Persistent Atrial Fibrillation and Enlarged Left Atrial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Left atrial size changes compared to baseline levels
研究概览
简要总结
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.
详细描述
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.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent atrial fibrillation undergoing catheter ablation within 2 weeks.
- •≥18 and ≤75 years of age.
- •Left atrium diameter（LAD）≥35mm, With or without right atrium diameter（RAD）≥40mm，diagnosed by Echocardiographic.
- •patient who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
- •Patients receiving ACE inhibitors (ACEI), angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit.
- •Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mmHg are eligible for enrollment if they are on three or more medications to control BP at randomization.
- •Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
- •Patients with a potassium ≤5.2 mmol/l at Visit 1.
排除标准
- •Patients with prosthetic valves.
- •Any previous LA suigery.
- •Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
- •Presence of hemodynamically significant mitral and /or aortic valve disease.
- •Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
- •Current acute decompensated HF requiring therapy.
- •Allergic to drugs or active ingredients (shakuba, valsartan) or any excipients。
- •Patients with previous history of angioedema associated with ACEI or ARB treatment.
- •Patient with hereditary or idiopathic angioedema.
- •patient with severe liver damage, biliary cirrhosis and cholestasis.
- •Patient with Renal artery stenosis.
研究组 & 干预措施
Sacubitril/valsartan
After catheter ablation, during a single blind, run-in period, participants received placebo. Then started with 50 mg sacubitril/valsarta 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.
干预措施: Sacubitril-Valsartan (Drug)
Valsartan
After catheter ablation,during a single blind, run-in period, participants received placebo. Then started with 40mg Valsartan twice daily qd for 2-4 weeks, then were uptitrated to 80mg qd or tolerable maximum dose ≥6 months.
干预措施: Valsartan (Drug)
结局指标
主要结局
Left atrial size changes compared to baseline levels
时间窗: 6months and 12 months
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.
次要结局
- all-cause death(12 months)
- Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction(12 months)
- Right atrial size changes compared to baseline levels(12 months)
- Time to first documented recurrence of atrial arrhythmias(12 months)
- Freedom from AF or AT without the use of antiarrhythmic drugs at 12 months after a single ablation procedure.(12 months)
- Number of hospitalizations caused by heart failure(12 months)
- All-cause hospitalizations(12 months)
- Number of patients requires adjustment of the drug because of Hypotension(12 months)
研究者
Yuehui Yin
professor
The Second Affiliated Hospital of Chongqing Medical University