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Effect of ARNI in Patients With Persistent AF and Enlarged Left Atrium After Catheter Ablation (APART-AF)

Primary Purpose

Atrial Fibrillation, Cardiac Remodeling, Atrial, Sacubitril/Valsartan

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Sacubitril-Valsartan

Valsartan

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Cardiac Remodeling, Sacubitril/Valsartan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacubitril/valsartan

Valsartan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

all-cause death

Time to first documented recurrence of atrial arrhythmias

Number of hospitalizations caused by heart failure

All-cause hospitalizations

Number of patients requires adjustment of the drug because of Hypotension

Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.

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.

Full Information

NCT ID

NCT03791723

First Posted

December 31, 2018

Last Updated

March 18, 2019

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03791723

Brief Title

Effect of ARNI in Patients With Persistent AF and Enlarged Left Atrium After Catheter Ablation

Acronym

APART-AF

Official Title

Efficacy and Safety of ARNI in Reversing Cardiac Remodeling After Catheter Ablation for Patient With Persistent Atrial Fibrillation and Enlarged Left Atrial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Anticipated)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 Diameter and Persistent AF.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Cardiac Remodeling, Atrial, Sacubitril/Valsartan

Keywords

Atrial Fibrillation, Cardiac Remodeling, Sacubitril/Valsartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

two groups,group one is for Sacubitril/valsartan 200mg bid or tolerable maximum dose, group two is for valsartan 80mg qd or tolerable maximum dose.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sacubitril/valsartan

Arm Type

Experimental

Arm Description

Arm Title

Valsartan

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sacubitril-Valsartan

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Left atrial size changes compared to baseline levels

Description

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

Secondary Outcome Measure Information:

Title

Freedom from AF or AT without the use of antiarrhythmic drugs at 12 months after a single ablation procedure.

Description

Time Frame

12 months

Title

all-cause death

Description

all-cause death

Time Frame

12 months

Title

Time to first documented recurrence of atrial arrhythmias

Description

Time to first documented recurrence of atrial arrhythmias

Time Frame

12 months

Title

Number of hospitalizations caused by heart failure

Description

Number of hospitalizations caused by heart failure

Time Frame

12 months

Title

All-cause hospitalizations

Description

All-cause hospitalizations

Time Frame

12 months

Title

Number of patients requires adjustment of the drug because of Hypotension

Description

Number of patients requires adjustment of the drug because of Hypotension

Time Frame

12 months

Title

Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction

Description

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.

Time Frame

12 months

Title

Right atrial size changes compared to baseline levels

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ZHIYU LING, MD

Phone

+8613512362075

lingzy1977@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

YANPING XU

Phone

+86-023-63693079

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29348971

Citation

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.

Results Reference

background

PubMed Identifier

29754651

Citation

Januzzi JL, Butler J, Fombu E, Maisel A, McCague K, Pina 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 Failure (PROVE-HF). Am Heart J. 2018 May;199:130-136. doi: 10.1016/j.ahj.2017.12.021. Epub 2018 Feb 13.

Results Reference

result

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Effect of ARNI in Patients With Persistent AF and Enlarged Left Atrium After Catheter Ablation

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