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

NCT03791723 | Unknown DMC

• 1 other identifier: APART-AF
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Cardiac Remodeling, Atrial; Sacubitril/Valsartan

Keywords

Atrial Fibrillation; Cardiac Remodeling; Sacubitril/Valsartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  12 months

• all-cause death

  12 months

• Time to first documented recurrence of atrial arrhythmias

  12 months

• Number of hospitalizations caused by heart failure

  12 months

• All-cause hospitalizations

  12 months

Study Arms (2)

Sacubitril/valsartan

EXPERIMENTAL

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.

Drug: Sacubitril-Valsartan

Valsartan

ACTIVE COMPARATOR

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.

Drug: Valsartan

Interventions

Sacubitril-Valsartan DRUG

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.

Sacubitril/valsartan

Valsartan DRUG

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.

Valsartan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Related 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.

  PMID: 29348971 BACKGROUND

• 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.

  PMID: 29754651 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Remodeling

Interventions

sacubitril and valsartan sodium hydrate drug combination; Valsartan

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

ZHIYU LING, MD

CONTACT

+8613512362075; lingzy1977@163.com

YANPING XU

CONTACT

+86-023-63693079

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: June 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: December 30, 2021
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share