Atrial Fibrillation Lifestyle Project

Atrial Fibrillation Paroxysmal Clinical Trial

— ALP  

Official title:

Atrial Fibrillation Lifestyle Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03724383
• Other study ID #: H18-01441
• Secondary ID: F18-02253
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: April 2020

Study information

• Verified date: October 2018
• Source: University of British Columbia
• Contact: Amy RN Booth, MPH
• Phone: 6044046343
• Email: amy.booth[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of the investigators are to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. Participants will be randomized into control or intervention groups. The intervention will receive step trackers, diet counselling, an exercise program, and risk factor modification consultations. Controls will receive step trackers and care as usual. Testing will occur at baseline, six months, and one year.

Description:

Sixty percent of cases of non-valvular AF are associated with other modifiable risk factors, including: obesity, diabetes, hypertension, or sleep apnea. Treating modifiable risk factors has been shown to improve morbidity and mortality in patients with AF. Treatment of AF with antiarrhythmic drugs or catheter ablation has not been shown to improve survival. Recently, small cohort studies combining exercise, diet, and antiarrhythmic medications and/or ablation have shown improvements in cardiovascular risk factors and reduction in AF symptoms and frequency.

The aim of this study is to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. This study uses a reproducible intensive supervised cardiac rehabilitation that includes exercise, diet, and risk factor modification for patients with paroxysmal, non-valvular AF. The investigators expect that a lifestyle intervention will show significant improvement in fitness and weight loss and improvements in AF symptoms and frequency, and cardiovascular risk factors when compared to a control group with paroxysmal AF and similar baseline characteristics who do not receive a diet and exercise program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. paroxysmal, non-permanent, non-valvular AF. Patients with high burden of AF will be admitted into the study ahead of low burden patients.

1. Low burden paroxysmal AF is defined as: =4 episodes of AF over the past 24 months; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.

2. High burden paroxysmal AF is defined as: = 4 episodes of AF over the past 6 months, with = 2 episodes > 6 hours in duration; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.

3. Early persistent AF is defined as: = 2 episodes of AF over the past 24 months; episodes are successfully terminated via cardioversion within 7 days of onset.

2. BMI equal to or greater than 27 kg/m^2, or central obesity using abdominal circumference with ethnic specific values recommended by Canadian diabetes association.

3. one of hypertension or diabetes

Exclusion Criteria:

1. Permanent AF

2. Estimated survival < 2 years

3. Left ventricular ejection fraction < 40%

4. Weight > 300 lbs, treadmill cannot hold greater weights

5. Inability to walk one city block

6. Severe musculoskeletal or neurological problems making them unable to exercise safely

7. New York Heart Association class 3-4 heart failure

8. Severe aortic valve stenosis

9. Prior mitral valve surgery or severe stenosis or regurgitation

10. Hypertrophic cardiomyopathy

11. Patients with illnesses or medications that already cause atrial fibrillation on their own, such as pericarditis, high doses of prednisone, and hyperthyroidism

12. Any other absolute and relative contraindications to exercise testing

13. Inability to speak and understand English

14. In atrial fibrillation at time of baseline testing

15. Defibrillator present

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal

Intervention

Behavioral:
• Risk Factor Management Consult
Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.
• Diet Classes
Group nutrition sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention) delivered by a registered dietitian.
• Stress Management Classes
Group sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention). Techniques taught will include awareness, coping, and relaxation strategies.

Other:
• Exercise Classes
Group sessions delivered two times per week (1 hr each), over 3 month period (months 3-6). Classes will include high intensity interval training, resistance training.
• Home based exercise program
The interval and resistance training program will mirror the supervised exercise.

Locations

Country	Name	City	State
Canada	Garratt Wellness Centre	Richmond	British Columbia
Canada	Richmond Cardiology Clinic	Richmond	British Columbia
Canada	Richmond Health Services	Richmond	British Columbia
Canada	Richmond Hospital Cardiac Rehabilitation	Richmond	British Columbia
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	Live Well Clinic	Vancouver	British Columbia
Canada	St. Paul's Healthy Heart Program	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Teddi Orenstein Lyall	University of British Columbia, Vancouver Coastal Health, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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Dorian P, Cvitkovic SS, Kerr CR, Crystal E, Gillis AM, Guerra PG, Mitchell LB, Roy D, Skanes AC, Wyse DG. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. Can J Cardiol. 2006 Apr;22(5):383-6. — View Citation

Dorian P, Jung W, Newman D, Paquette M, Wood K, Ayers GM, Camm J, Akhtar M, Luderitz B. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol. 2000 Oct;36(4):1303-9. — View Citation

Elliott AD, Maatman B, Emery MS, Sanders P. The role of exercise in atrial fibrillation prevention and promotion: Finding optimal ranges for health. Heart Rhythm. 2017 Nov;14(11):1713-1720. doi: 10.1016/j.hrthm.2017.07.001. Epub 2017 Jul 8. Review. — View Citation

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Hong KL, Glover BM. The impact of lifestyle intervention on atrial fibrillation. Curr Opin Cardiol. 2018 Jan;33(1):14-19. doi: 10.1097/HCO.0000000000000470. Review. — View Citation

Huxley RR, Lopez FL, Folsom AR, Agarwal SK, Loehr LR, Soliman EZ, Maclehose R, Konety S, Alonso A. Absolute and attributable risks of atrial fibrillation in relation to optimal and borderline risk factors: the Atherosclerosis Risk in Communities (ARIC) study. Circulation. 2011 Apr 12;123(14):1501-8. doi: 10.1161/CIRCULATIONAHA.110.009035. Epub 2011 Mar 28. — View Citation

Jonasson D, Irvine S, Starkey S, Su S, Johal R, Sweeney P, et al. SCREENING FOR OBSTRUCTIVE SLEEP APNEA (OSA) IN ATRIAL FIBRILLATION (AF): WHAT'S THE BEST TEST? Can J Cardiol [Internet]. 2017 Oct 1 [cited 2018 Jan 24];33(10):S195.

Lee GA, Stub D, Ling H. Atrial fibrillation in the elderly -- not a benign condition. Int Emerg Nurs. 2012 Oct;20(4):221-7. doi: 10.1016/j.ienj.2012.05.003. Epub 2012 Jul 4. — View Citation

Macle L, Cairns J, Leblanc K, Tsang T, Skanes A, Cox JL, Healey JS, Bell A, Pilote L, Andrade JG, Mitchell LB, Atzema C, Gladstone D, Sharma M, Verma S, Connolly S, Dorian P, Parkash R, Talajic M, Nattel S, Verma A; CCS Atrial Fibrillation Guidelines Committee. 2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2016 Oct;32(10):1170-1185. doi: 10.1016/j.cjca.2016.07.591. Epub 2016 Sep 6. Review. Erratum in: Can J Cardiol. 2017 Apr;33(4):552-553. — View Citation

Malmo V, Nes BM, Amundsen BH, Tjonna AE, Stoylen A, Rossvoll O, Wisloff U, Loennechen JP. Aerobic Interval Training Reduces the Burden of Atrial Fibrillation in the Short Term: A Randomized Trial. Circulation. 2016 Feb 2;133(5):466-73. doi: 10.1161/CIRCULATIONAHA.115.018220. Epub 2016 Jan 5. — View Citation

Miyazaki S, Taniguchi H, Kusa S, Nakamura H, Hachiya H, Hirao K, Iesaka Y. Five-year follow-up outcome after catheter ablation of persistent atrial fibrillation using a sequential biatrial linear defragmentation approach: What does atrial fibrillation termination during the procedure imply? Heart Rhythm. 2017 Jan;14(1):34-40. doi: 10.1016/j.hrthm.2016.08.041. Epub 2016 Aug 30. — View Citation

Neumann T, Wójcik M, Berkowitsch A, Erkapic D, Zaltsberg S, Greiss H, Pajitnev D, Lehinant S, Schmitt J, Hamm CW, Pitschner HF, Kuniss M. Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success. Europace. 2013 Aug;15(8):1143-9. doi: 10.1093/europace/eut021. Epub 2013 Feb 17. — View Citation

Pathak RK, Elliott A, Middeldorp ME, Meredith M, Mehta AB, Mahajan R, Hendriks JM, Twomey D, Kalman JM, Abhayaratna WP, Lau DH, Sanders P. Impact of CARDIOrespiratory FITness on Arrhythmia Recurrence in Obese Individuals With Atrial Fibrillation: The CARDIO-FIT Study. J Am Coll Cardiol. 2015 Sep 1;66(9):985-96. doi: 10.1016/j.jacc.2015.06.488. Epub 2015 Jun 22. — View Citation

Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart. 2004 Mar;90(3):286-92. Erratum in: Heart. 2007 Nov;93(11):1472. Murphy, N [corrected to Murphy, N F]. — View Citation

Tsang TS, Barnes ME, Bailey KR, Leibson CL, Montgomery SC, Takemoto Y, Diamond PM, Marra MA, Gersh BJ, Wiebers DO, Petty GW, Seward JB. Left atrial volume: important risk marker of incident atrial fibrillation in 1655 older men and women. Mayo Clin Proc. 2001 May;76(5):467-75. — View Citation

Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Risks for atrial fibrillation and congestive heart failure in patients >/=65 years of age with abnormal left ventricular diastolic relaxation. Am J Cardiol. 2004 Jan 1;93(1):54-8. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency of atrial fibrillation	The frequency of AF will be measured with 48-hour Holter monitor recording, looking at percent of time in AF.	Baseline to 6 months and 1 year
Primary	Changes in severity of atrial fibrillation	Assessed using the Canadian Cardiovascular Society Severity in Atrial Fibrillation Scale (CCS-SAF), and the Atrial Fibrillation Symptom Severity Scale (AFSS).; The CCS-SAF categorizes severity of atrial fibrillation from Class 0 to Class 4, with 0 being asymptomatic and 4 being severe.; On the AFSS, individual symptoms attributable to AF are scored on a five-point Likert scale, such that the total AFSS severity score ranges from 0 to 35, with higher scores indicating increased AFSS.; These two scales will be used simultaneously to inform the severity of Atrial Fibrillation.	Baseline to 6 months and 1 year
Primary	Changes in Quality of Life on SF36	The 36-item Short Form Survey Instrument (SF36) measures quality of life. Each question is scored on a Likert scale with varying ranges (0-3, 0-5, etc.). Using a score conversion toolkit, the score for each question is converted to a value out of 100, such that lower scores indicate lower quality of life and higher scores indicate a higher quality of life. Those scores out of 100 can be added to get a score out of 3600, but the quality of life is most often reported as a percent.	Baseline to 6 months and 1 year
Secondary	Changes in number of medications	Total number of all anti-arrhythmic agents, anti-hypertensive agents, diabetes and cholesterol lowering medications will be recorded and compared.	Baseline and 1 year
Secondary	Systolic and Diastolic Blood Pressure	Measured in mmHg.; For a normal reading, your blood pressure needs to show a top number (systolic pressure) that's between 90 and less than 120 and a bottom number (diastolic pressure) that's between 60 and less than 80.	Baseline, 6 months, 1 year
Secondary	Hemoglobin A1C	The hemoglobin A1c test tells you your average level of blood sugar over the past 2 to 3 months. It's also called HbA1c, glycated hemoglobin test, and glycohemoglobin.; It is reported in percentages.	Baseline, 6 months, 1 year
Secondary	Body Mass Index	Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. BMI is universally expressed in units of kg/m^2.	Baseline, 6 months, 1 year
Secondary	Waist Circumference	Waist circumference is an indicator of health risk associated with excess fat around the waist. A waist circumference of 102 centimetres (40 inches) or more in men, or 88 centimetres (35 inches) or more in women, is associated with health problems such as type 2 diabetes, heart disease and high blood pressure	Baseline, 6 months, 1 year
Secondary	Relative Fat Mass	Relative Fat Mass (RFM) is a measure for the estimation of overweight or obesity in humans.; The ratio or the patient's height and waist measurements in meters is multiplied by 20 before being subtracted from a number (shown in bold below) that adjusts for differences in gender and height: RFM for adult males: 64 - (20 x height in meters divided waist circumference in meters) RFM for adult females:76 - (20 x height in metres divided by waist circumference in meters)	Baseline, 6 months, 1 year
Secondary	Low density lipoprotein	Low-density lipoprotein (LDL) is one of the body's lipoproteins and an important carrier of cholesterol. LDL is an important marker for the risk of developing heart disease.; LDL cholesterol levels should be less than 100 mg/dL. Levels of 100 to 129 mg/dL are acceptable for people with no health issues but may be of more concern for those with heart disease or heart disease risk factors. A reading of 130 to 159 mg/dL is borderline high and 160 to 189 mg/dL is high.	Baseline, 6 months, 1 year
Secondary	Apnea hypopnea index	The Apnea Hypopnea Index (AHI) is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of obstructive sleep apnea is classified as follows: None/Minimal: AHI < 5 per hour Mild: AHI = 5, but < 15 per hour Moderate: AHI = 15, but < 30 per hour Severe: AHI = 30 per hour	Baseline, 6 months, 1 year
Secondary	Metabolic equivalents (METs)	Fitness will be classified using metabolic equivalents (METs).; One MET is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min. The energy cost of an activity can be determined by dividing the relative oxygen cost of the activity (ml O2/kg/min) x by 3.5. This study will measure metabolic equivalents achieved on exercise stress test.	Baseline, 6 months, 1 year
Secondary	Left Atrial Volume Index	The Left Atrial Volume Index (LAVI) is the left atrial volume relative to Body Surface Area (BSA), and is reported in mL/m^2.; Ranges of LAVI Reference Range 16-28 Mildly Abnormal 29-33 Moderately Abnormal 34-39 Severely Abnormal =40	Baseline,1 year
Secondary	Diastolic Function Grade	here are four grades of diastolic dysfunction as described below. Echocardiography is the gold standard to diagnose diastolic dysfunction.; Grade I (impaired relaxation): This is a normal finding and occurs in nearly 100% of individuals by the age of 60.; Grade II (pseudonormal): This is pathological and results in elevated left atrial pressures.; Grade III (reversible restrictive): This results in significantly elevated left atrial pressures.; Grade IV (fixed restrictive): This indicates a poor prognosis and very elevated left atrial pressures.	Baseline, 1 year
Secondary	Left Atrial Pressure	Left atrial pressure (LAP) can be estimated by measuring the systolic blood pressure and the maximum mitral regurgitation velocity by spectral Doppler provided that there is no significant gradient across the aortic valve.; Left Atrial Pressure is reported in mmHg	Baseline, 1 year