Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

Atrial Fibrillation Clinical Trial

— RASTA-AF  

Official title:

Reversal of Atrial Substrate to Prevent Atrial Fibrillation - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186976
• Other study ID #: RP-004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It is associated with a six-fold risk of stroke and a two-fold increase in mortality, the main cardiac reason for death one year after presenting to the emergency department with AF is heart failure. It results in high healthcare costs, recurrent ED visits and hospitalizations. The burden of disability associated with AF has been found to increase by 20% from 1990-2010. AF was also cited as one of the seven causes of death that has been increasing worldwide. Prevention of AF has not been a focus of past treatments and it is well known that elevated body mass index, hypertension, smoking, increased alcohol intake, lack of exercise and sleep apnea are risk factors for AF. There is a lack of randomized, multicenter data proving that a strategy of aggressive risk factor modification will prevent and modify AF.

Upstream therapy for AF has been of considerable interest, and benefit has been demonstrated in primary prevention of AF. Catheter ablation has demonstrated success over current medical therapies for long-term rhythm control, but recurrence remains high, irrespective of ablation strategy. This study is a feasibility study to determine whether a complex and multi-component risk factor modification can be successfully implemented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Aggressive Risk Factor Control
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%

Other:
• Standard of Care
Recommendations based on current guidelines

Locations

Country	Name	City	State
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Canadian Cardiovascular Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of recruitment	Recruitment of =2.8 patients/center/month over three centers, thereby completing recruitment in 6 months	6 months