Status:
UNKNOWN
Effect of ARNI in Patients With Persistent AF and Enlarged Left Atrium After Catheter Ablation
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Conditions:
Atrial Fibrillation
Cardiac Remodeling, Atrial
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 Dia...
Detailed Description
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 ri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03791723
Start Date
June 1 2019
End Date
December 30 2021
Last Update
March 19 2019
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