QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
NCT Number: NCT03186976
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3H 3A7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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
1.) Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5.
Recommendations based on current guidelines
Time frame: 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.
Time frame: 6 months
Recruitment of ≥2.8 patients/center/month over three centers, thereby completing recruitment in 6 months
Nova Scotia Health Authority
Other
Reversal of Atrial Substrate to Prevent Atrial Fibrillation - A Pilot Study
Acronym: RASTA-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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