NCT03186976

Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-10-31
• Completion: 2019-11-30
• First posted: 2017-06-14
• Last updated: 2019-12-18

Locations

1 site across 1 country: Canada