Atrial Fibrillation Clinical Trial
— APART-AFOfficial title:
Efficacy and Safety of ARNI in Reversing Cardiac Remodeling After Catheter Ablation for Patient With Persistent Atrial Fibrillation and Enlarged Left Atrial
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.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | December 30, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients with persistent atrial fibrillation undergoing catheter ablation within 2 weeks. 2. =18 and =75 years of age. 3. Left atrium diameter(LAD)=35mm, With or without right atrium diameter(RAD)=40mm,diagnosed by Echocardiographic. 4. patient who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol. 5. 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. 6. 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. 7. Patients must have an eGFR = 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula). 8. Patients with a potassium =5.2 mmol/l at Visit 1. Exclusion Criteria: 1. Patients with prosthetic valves. 2. Any previous LA suigery. 3. 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. 4. Presence of hemodynamically significant mitral and /or aortic valve disease. 5. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis. 6. Current acute decompensated HF requiring therapy. 7. Allergic to drugs or active ingredients (shakuba, valsartan) or any excipients? 8. Patients with previous history of angioedema associated with ACEI or ARB treatment. 9. Patient with hereditary or idiopathic angioedema. 10. patient with severe liver damage, biliary cirrhosis and cholestasis. 11. Patient with Renal artery stenosis. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Second Affiliated Hospital of Chongqing Medical University |
Almufleh A, Marbach J, Chih S, Stadnick E, Davies R, Liu P, Mielniczuk L. Ejection fraction improvement and reverse remodeling achieved with Sacubitril/Valsartan in heart failure with reduced ejection fraction patients. Am J Cardiovasc Dis. 2017 Dec 20;7(6):108-113. eCollection 2017. — View Citation
Januzzi JL, Butler J, Fombu E, Maisel A, McCague K, Piña IL, Prescott MF, Riebman JB, Solomon S. Rationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Fa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6months and 12 months | |
Secondary | 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. | 12 months | |
Secondary | all-cause death | all-cause death | 12 months | |
Secondary | Time to first documented recurrence of atrial arrhythmias | Time to first documented recurrence of atrial arrhythmias | 12 months | |
Secondary | Number of hospitalizations caused by heart failure | Number of hospitalizations caused by heart failure | 12 months | |
Secondary | All-cause hospitalizations | All-cause hospitalizations | 12 months | |
Secondary | Number of patients requires adjustment of the drug because of Hypotension | Number of patients requires adjustment of the drug because of Hypotension | 12 months | |
Secondary | Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. | 12 months | |
Secondary | 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. | 12 months |
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