RASTA-AF: Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Completed

CT.gov ID

NCT03186976

Collaborator

Canadian Cardiovascular Society (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Behavioral: Aggressive Risk Factor Control Other: Standard of Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aggressive Risk Factor Control Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management	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%
Active Comparator: Standard of Care 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 Recommendations based on current guidelines

Arm

Intervention/Treatment

Experimental: Aggressive Risk Factor Control

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

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%

Active Comparator: Standard of Care

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

Recommendations based on current guidelines

Outcome Measures

Primary Outcome Measures

adherence to the risk factor intervention [6 months]
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.

Secondary Outcome Measures

Feasibility of recruitment [6 months]
Recruitment of ≥2.8 patients/center/month over three centers, thereby completing recruitment in 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QE II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 3A7

Sponsors and Collaborators

Nova Scotia Health Authority
Canadian Cardiovascular Society

Investigators

Principal Investigator: Ratika Parkash, Nova Scotia Health Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ratika Parkash, MD, FRCPC, Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT03186976

Other Study ID Numbers:

RP-004

First Posted:

Jun 14, 2017

Last Update Posted:

Dec 18, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ratika Parkash, MD, FRCPC, Nova Scotia Health Authority

Risk Factor Modification

Catheter ablation

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Dec 18, 2019