Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

NCT03186976 | Completed

• 1 other identifier: RP-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Keywords

Risk Factor Modification; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• adherence to the risk factor intervention

  80% compliance to each of the components: 150 minutes exercise/week, BP target as per CHEP guidelines, alcohol limits, smoking cessation, and sleep apnea therapy, hemoglobin A1C\<6.5% at the end of follow up. If 80% of individuals can reach these 80% of the time, the adherence criteria will be met.

  6 months

Secondary Outcomes (1)

• Feasibility of recruitment

  6 months

Study Arms (2)

Aggressive Risk Factor Control

EXPERIMENTAL

Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management

Behavioral: Aggressive Risk Factor Control

Standard of Care

ACTIVE COMPARATOR

All patients in the control arm will receive therapies for AF as per the existing guidelines. BP, cholesterol, diabetic management will be administered as per the available guidelines.

Other: Standard of Care

Interventions

Aggressive Risk Factor Control BEHAVIORAL

1.) Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5. 2\) Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (\>5 drinks at one setting). 3\) Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise. 4\) An OMRON BP monitor will be supplied to each patient. A target SBP of \<140/80 mm/Hg will be targeted. 5\) Smoking cessation - through local resources already established at each site 6) Management of diabetes to achieve HgA1c\<6.5%

Aggressive Risk Factor Control

Standard of Care OTHER

Recommendations based on current guidelines

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Patients with symptomatic (CCS-SAF ≥2) recurrent paroxysmal or persistent nonvalvular atrial fibrillation despite rate control, desiring catheter ablation AND
• one of : BMI\>27, BP\>140/90 or history of hypertension, alcohol use \> recommended limit, current smoking, diabetes with HgA1C\>7%, physical inactivity (\<150 minutes/week).
• (Definitions: Recurrent paroxysmal - at least 4 episodes of symptomatic AF in the prior 6 months, with or without cardioversion; Persistent AF lasting greater than 7 days but less than 3 years; AF must be documented on a Holter, rhythm strip or electrocardiogram within the last 24 months.)

You may not qualify if:

• Permanent AF (AF lasting \> 3 years)
• Prior catheter ablation for AF
• Left ventricular ejection fraction \<30%
• Left atrial size \> 5.5 cm
• NYHA IV heart failure
• Participation in a cardiac rehabilitation program within the last year
• Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
• Unable to exercise
• Unable to give informed consent
• Other noncardiovascular medical condition making 1 year survival unlikely

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Cardiovascular Society: collaborator

Study Sites (1)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ratika Parkash

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This will be a parallel group, open label randomized clinical trial, with blinded endpoint evaluation (PROBE design)

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 14, 2017
• Study Start: May 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)