Cognitive Function in Patients With Persisted Atrial Fibrillation (SMART-AF)

The Best Treatment Strategy for the Reservation of Cognitive Function in Patients With Persisted Atrial Fibrillation

Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

Study Overview

• Status: Enrolling by invitation
• Conditions: Cognitive Function; Atrial Fibrillation, Persistent
• Intervention / Treatment: Other: Rhythm control; Other: Rate control

Detailed Description

The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain.

The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Chih-Chieh, MD.PhD; Phone Number: 65257 886-2-23123456; Email: sweetchieh@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions:

   • The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis.
   • 24 hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis.
   • The seven-day ECG recorder diagnosed 100% atrial fibrillation.
2. Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.

Exclusion Criteria:

1. Unwilling to sign the clinical trial consent form.
2. Unable to complete the cognitive function questionnaire.
3. Unable to complete brain MRI examination due to various reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhythm control; Rhythm control with medication or any procedure	Other: Rhythm control; Rhythm control with medications or any procedure
Active Comparator: Rate control; Rate control with medication or any procedure	Other: Rate control; Rate control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	MOCA questionnaire	12 months
Cognitive function	brain MRI	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life questionnaire	SF-36 questionnaire	12 months
Hospitalization for cardiovascular cause		12 months
all cause mortality		12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cognitive Function
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 201912175RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No