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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03791723
Other study ID # APART-AF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date December 30, 2021

Study information

Verified date March 2019
Source The Second Affiliated Hospital of Chongqing Medical University
Contact ZHIYU LING, MD
Phone +8613512362075
Email lingzy1977@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 Diameter and Persistent AF.


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 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Sacubitril-Valsartan
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.
Valsartan
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

References & Publications (2)

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

Outcome

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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