Recruiting

Lifestyle Modification

Sponsor:

Dr. Benedict Glover

Code:

NCT03785418

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multicomponent Risk Factor Modification

Study Details

Brief summary:

The purpose of this study is to evaluate the effectiveness of a lifestyle modification intervention focused on healthy eating, regular exercise and behavioural therapy to decrease the length and number of atrial fibrillation episodes as well as gain an understanding of the impact of these changes on the gut microbiome.

Conditions

Atrial Fibrillation

Study ID

NCT03785418

Start date

Oct 29, 2018

Status verified date

Dec, 2018

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • paroxysmal or persistent AFIB (in sinus rhythm at the time of randomization)
  • BMI > 30 kg/m\^2 or a waist circumference greater than 100 cm (male) or 90 cm (female)
  • have daily access to an iPhone
  • have at least one of the following risk factors:hypertension, diabetes or pre-diabetes, hyperlipidemia, smoker, obstructive sleep apnea

Exclusion Criteria:

  • Permanent AFIB (AFIB lasting > 1 year)
  • Prior or actively on waiting list for catheter ablation for AFIB
  • History of unstable angina not corrected with revascularization
  • Left ventricular ejection fraction <30%
  • Left atrial size >5.5 cm
  • New York Heart Association (NYHA) classification IV heart failure
  • Moderate or severe cardiac valvular lesion (stenosis or regurgitation) on echocardiography or valvular lesion requiring intervention.
  • Participation in a cardiac rehabilitation program within the last year
  • Serious underlying psychiatric disorder: e.g. eating disorder, severe psychotic disorder with recent (3 month) hospitalization or psychiatric illness requiring supervised care precluding full independent function.
  • Participants who are unable or unwilling to provide fully informed consent.
  • Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
  • Gastrointestinal malabsorption disorder: A previously diagnosed gastrointestinal malabsorption disorder interfering with macro or micronutrient absorption.
  • If receiving warfarin and unstable international normalized ratio (INR) defined as persistently outside of the therapeutic range (2.0-3.0) for greater than 14 consecutive days.
  • Other non-cardiovascular medical conditions making 1-year survival unlikely.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

Multicomponent Risk Factor Modification Intervention focused on healthy eating, regular exercise and behavioural therapy

no intervention: Control Arm

Standard Clinical Practice

Interventions

Multicomponent Risk Factor Modification

Healthy eating, regular exercise and behavioural therapy.

Primary outcome measure

  • Changes in AFIB-related symptom burden [ Time Frame: baseline to 1, 3, 6 and 12 months ]
  • Changes in AFIB burden [ Time Frame: baseline to 1, 3, 6, and 12 months ]
  • Changes in Quality of Life based on Treatment Concerns and Daily Activity [ Time Frame: baseline to 1, 3, 6, and 12 months ]
  • Combined incidence of stroke, myocardial infarction and hospitalization [ Time Frame: 12 months ]
  • Changes in levels of monosaccharides in the gut microbiota [ Time Frame: baseline to 12 months ]
  • Changes in levels of short-chain fatty acids in the gut microbiota [ Time Frame: baseline to 12 months ]

Central Contacts and Locations

Central contacts

Christopher Simpson, MD

6135496666simpsonc@kgh.kari.net

Milena A Bullen, BScH

613549666612mb98@queensu.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L2V7

Contacts

Christopher Simpson, MD

6135496666simpsonc@kgh.kari.net

Milena A Bullen, BScH

613549666612mb98@queensu.ca

Principal Investigator:

Christopher Simpson, MD

More Information

Sponsor

Dr. Benedict Glover

Last update posted

Dec 26, 2018

Last verified

Dec, 2018

Keywords

  • Atrial Fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Benedict Glover on 2018-12-26.