Lifestyle Modification for the Treatment of Symptomatic Atrial Fibrillation (LIFE-AF)

NCT03785418 | Unknown

• 1 other identifier: 6022511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• Changes in AFIB-related symptom burden

  To assess the impact of a lifestyle intervention on AFIB-related symptom burden as measured by the University of Toronto AFIB Severity Scale (AFSS) scores at 1, 3, 6, and 12 months. This is a validated scale (range, 3.25 \[single minimally symptomatic episode lasting minutes\] to 30 \[continuous highly symptomatic episode lasting \>48hours\]) which encompasses 3 domains of atrial fibrillation: event frequency (scored 1-10), duration (scored 1.25-10), and global episode severity (scored 1-10).

  baseline to 1, 3, 6 and 12 months

• Changes in AFIB burden

  To assess the impact of a lifestyle intervention on AFIB burden as documented from implantable loop recorders at 1, 3, 6 and 12 months. We will document the change in the number of AFIB episodes. This will be monitored by the ILR recording device where any episode of AFIB over 30 seconds will count as 1 episode. The AFIB events recorded by the device will be adjudicated for accuracy using 2 raters.

  baseline to 1, 3, 6, and 12 months

• Changes in Quality of Life based on Treatment Concerns and Daily Activity

  To assess the impact of a lifestyle intervention (multicomponent risk factor modification) on quality of life at 1, 3, 6, and 12-months using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire. This assesses treatment concerns and daily activity.

  baseline to 1, 3, 6, and 12 months

• Combined incidence of stroke, myocardial infarction and hospitalization

  To assess the impact of a lifestyle intervention on a composite end-point at 12 months (combined stroke, myocardial infarction and hospitalization). This information will be collected from hospital records.

  12 months

• Changes in levels of monosaccharides in the gut microbiota

  Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of monosaccharides in the gut microbiota at baseline and at 12 months.

  baseline to 12 months

• Changes in levels of short-chain fatty acids in the gut microbiota

  Identification of the gastrointestinal microbiota composition at baseline and dysbiosis at 12 months as a result of dietary intervention. Microbial DNA will be extracted from fecal samples, 16S rRNA genes will be amplified, and analyses will be performed to determine levels of short-chain fatty acids in the gut microbiota at baseline and at 12 months.

  baseline to 12 months

Secondary Outcomes (6)

• Change in weight

  baseline to 1, 3, 6 and 12 months

• Adherence to the lifestyle intervention physical activity recommendations using IPAQ

  1, 3, 6 and 12 months

• Changes in Physical Activity Levels Based on Step-Counts

  1, 3, 6, and 12 months

• Adherence to the lifestyle intervention physical activity recommendations using MESA TWPAS

  1, 3, 6 and 12 months

• Adherence to the lifestyle intervention diet recommendations

  1, 3, 6 and 12 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Behavioral: Multicomponent Risk Factor Modification

Control Arm

NO INTERVENTION

Standard Clinical Practice

Interventions

Multicomponent Risk Factor Modification BEHAVIORAL

Healthy eating, regular exercise and behavioural therapy.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Benedict Glover: lead
• Abbott: collaborator
• University of Toronto: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

RECRUITING

Related Publications (40)

• Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.

  PMID: 24345399 BACKGROUND

• Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.

  PMID: 16818816 BACKGROUND

• Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.

  PMID: 1866765 BACKGROUND

• Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Kay GN, Le Huezey JY, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann LS, Smith SC Jr, Priori SG, Estes NA 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, Jacobs AK, Anderson JL, Albert N, Buller CE, Creager MA, Ettinger SM, Guyton RA, Halperin JL, Hochman JS, Kushner FG, Ohman EM, Stevenson WG, Tarkington LG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011 Mar 15;123(10):e269-367. doi: 10.1161/CIR.0b013e318214876d. Epub 2011 Mar 7. No abstract available.

  PMID: 21382897 BACKGROUND

• Lau DH, Nattel S, Kalman JM, Sanders P. Modifiable Risk Factors and Atrial Fibrillation. Circulation. 2017 Aug 8;136(6):583-596. doi: 10.1161/CIRCULATIONAHA.116.023163.

  PMID: 28784826 BACKGROUND

• Lavie CJ, Pandey A, Lau DH, Alpert MA, Sanders P. Obesity and Atrial Fibrillation Prevalence, Pathogenesis, and Prognosis: Effects of Weight Loss and Exercise. J Am Coll Cardiol. 2017 Oct 17;70(16):2022-2035. doi: 10.1016/j.jacc.2017.09.002.

  PMID: 29025560 BACKGROUND

• Nalliah CJ, Sanders P, Kalman JM. Obesity and atrial fibrillation outcomes and risk: Increasing the weight of evidence. Heart Rhythm. 2017 Jun;14(6):828-829. doi: 10.1016/j.hrthm.2017.03.013. Epub 2017 Mar 15. No abstract available.

  PMID: 28315404 BACKGROUND

• Dublin S, French B, Glazer NL, Wiggins KL, Lumley T, Psaty BM, Smith NL, Heckbert SR. Risk of new-onset atrial fibrillation in relation to body mass index. Arch Intern Med. 2006 Nov 27;166(21):2322-8. doi: 10.1001/archinte.166.21.2322.

  PMID: 17130384 BACKGROUND

• Guijian L, Jinchuan Y, Rongzeng D, Jun Q, Jun W, Wenqing Z. Impact of body mass index on atrial fibrillation recurrence: a meta-analysis of observational studies. Pacing Clin Electrophysiol. 2013 Jun;36(6):748-56. doi: 10.1111/pace.12106. Epub 2013 Feb 25.

  PMID: 23437987 BACKGROUND

• Wong CX, Ganesan AN, Selvanayagam JB. Epicardial fat and atrial fibrillation: current evidence, potential mechanisms, clinical implications, and future directions. Eur Heart J. 2017 May 1;38(17):1294-1302. doi: 10.1093/eurheartj/ehw045.

  PMID: 26935271 BACKGROUND

• Pathak RK, Middeldorp ME, Meredith M, Mehta AB, Mahajan R, Wong CX, Twomey D, Elliott AD, Kalman JM, Abhayaratna WP, Lau DH, Sanders P. Long-Term Effect of Goal-Directed Weight Management in an Atrial Fibrillation Cohort: A Long-Term Follow-Up Study (LEGACY). J Am Coll Cardiol. 2015 May 26;65(20):2159-69. doi: 10.1016/j.jacc.2015.03.002. Epub 2015 Mar 16.

  PMID: 25792361 BACKGROUND

• Abed HS, Wittert GA, Leong DP, Shirazi MG, Bahrami B, Middeldorp ME, Lorimer MF, Lau DH, Antic NA, Brooks AG, Abhayaratna WP, Kalman JM, Sanders P. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013 Nov 20;310(19):2050-60. doi: 10.1001/jama.2013.280521.

  PMID: 24240932 BACKGROUND

• Beto JA, Schury KA, Bansal VK. Strategies to promote adherence to nutritional advice in patients with chronic kidney disease: a narrative review and commentary. Int J Nephrol Renovasc Dis. 2016 Feb 2;9:21-33. doi: 10.2147/IJNRD.S76831. eCollection 2016.

  PMID: 26893578 BACKGROUND

• Tesfaye S, Chaturvedi N, Eaton SE, Ward JD, Manes C, Ionescu-Tirgoviste C, Witte DR, Fuller JH; EURODIAB Prospective Complications Study Group. Vascular risk factors and diabetic neuropathy. N Engl J Med. 2005 Jan 27;352(4):341-50. doi: 10.1056/NEJMoa032782.

  PMID: 15673800 BACKGROUND

• Dimmer C, Tavernier R, Gjorgov N, Van Nooten G, Clement DL, Jordaens L. Variations of autonomic tone preceding onset of atrial fibrillation after coronary artery bypass grafting. Am J Cardiol. 1998 Jul 1;82(1):22-5. doi: 10.1016/s0002-9149(98)00231-8.

  PMID: 9671003 BACKGROUND

• Dublin S, Glazer NL, Smith NL, Psaty BM, Lumley T, Wiggins KL, Page RL, Heckbert SR. Diabetes mellitus, glycemic control, and risk of atrial fibrillation. J Gen Intern Med. 2010 Aug;25(8):853-8. doi: 10.1007/s11606-010-1340-y. Epub 2010 Apr 20.

  PMID: 20405332 BACKGROUND

• Di Carli MF, Bianco-Batlles D, Landa ME, Kazmers A, Groehn H, Muzik O, Grunberger G. Effects of autonomic neuropathy on coronary blood flow in patients with diabetes mellitus. Circulation. 1999 Aug 24;100(8):813-9. doi: 10.1161/01.cir.100.8.813.

  PMID: 10458716 BACKGROUND

• Sacre JW, Franjic B, Jellis CL, Jenkins C, Coombes JS, Marwick TH. Association of cardiac autonomic neuropathy with subclinical myocardial dysfunction in type 2 diabetes. JACC Cardiovasc Imaging. 2010 Dec;3(12):1207-15. doi: 10.1016/j.jcmg.2010.09.014.

  PMID: 21163448 BACKGROUND

• Pop-Busui R, Kirkwood I, Schmid H, Marinescu V, Schroeder J, Larkin D, Yamada E, Raffel DM, Stevens MJ. Sympathetic dysfunction in type 1 diabetes: association with impaired myocardial blood flow reserve and diastolic dysfunction. J Am Coll Cardiol. 2004 Dec 21;44(12):2368-74. doi: 10.1016/j.jacc.2004.09.033.

  PMID: 15607400 BACKGROUND

• Chung MK, Martin DO, Sprecher D, Wazni O, Kanderian A, Carnes CA, Bauer JA, Tchou PJ, Niebauer MJ, Natale A, Van Wagoner DR. C-reactive protein elevation in patients with atrial arrhythmias: inflammatory mechanisms and persistence of atrial fibrillation. Circulation. 2001 Dec 11;104(24):2886-91. doi: 10.1161/hc4901.101760.

  PMID: 11739301 BACKGROUND

• Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.

  PMID: 23364002 BACKGROUND

• Mitsou EK, Kakali A, Antonopoulou S, Mountzouris KC, Yannakoulia M, Panagiotakos DB, Kyriacou A. Adherence to the Mediterranean diet is associated with the gut microbiota pattern and gastrointestinal characteristics in an adult population. Br J Nutr. 2017 Jun;117(12):1645-1655. doi: 10.1017/S0007114517001593.

  PMID: 28789729 BACKGROUND

• Schiffrin EL, Campbell NR, Feldman RD, Kaczorowski J, Lewanczuk R, Padwal R, Tobe SW. Hypertension in Canada: Past, Present, and Future. Ann Glob Health. 2016 Mar-Apr;82(2):288-99. doi: 10.1016/j.aogh.2016.02.006.

  PMID: 27372532 BACKGROUND

• Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

  PMID: 12748199 BACKGROUND

• McAlister FA, Wilkins K, Joffres M, Leenen FH, Fodor G, Gee M, Tremblay MS, Walker R, Johansen H, Campbell N. Changes in the rates of awareness, treatment and control of hypertension in Canada over the past two decades. CMAJ. 2011 Jun 14;183(9):1007-13. doi: 10.1503/cmaj.101767. Epub 2011 May 16.

  PMID: 21576297 BACKGROUND

• Pathak RK, Middeldorp ME, Lau DH, Mehta AB, Mahajan R, Twomey D, Alasady M, Hanley L, Antic NA, McEvoy RD, Kalman JM, Abhayaratna WP, Sanders P. Aggressive risk factor reduction study for atrial fibrillation and implications for the outcome of ablation: the ARREST-AF cohort study. J Am Coll Cardiol. 2014 Dec 2;64(21):2222-31. doi: 10.1016/j.jacc.2014.09.028. Epub 2014 Nov 24.

  PMID: 25456757 BACKGROUND

• Moore SC, Patel AV, Matthews CE, Berrington de Gonzalez A, Park Y, Katki HA, Linet MS, Weiderpass E, Visvanathan K, Helzlsouer KJ, Thun M, Gapstur SM, Hartge P, Lee IM. Leisure time physical activity of moderate to vigorous intensity and mortality: a large pooled cohort analysis. PLoS Med. 2012;9(11):e1001335. doi: 10.1371/journal.pmed.1001335. Epub 2012 Nov 6.

  PMID: 23139642 BACKGROUND

• Hunter GR, Kekes-Szabo T, Snyder SW, Nicholson C, Nyikos I, Berland L. Fat distribution, physical activity, and cardiovascular risk factors. Med Sci Sports Exerc. 1997 Mar;29(3):362-9. doi: 10.1097/00005768-199703000-00011.

  PMID: 9139175 BACKGROUND

• Papaetis GS, Papakyriakou P, Panagiotou TN. Central obesity, type 2 diabetes and insulin: exploring a pathway full of thorns. Arch Med Sci. 2015 Jun 19;11(3):463-82. doi: 10.5114/aoms.2015.52350.

  PMID: 26170839 BACKGROUND

• Goto C, Higashi Y, Kimura M, Noma K, Hara K, Nakagawa K, Kawamura M, Chayama K, Yoshizumi M, Nara I. Effect of different intensities of exercise on endothelium-dependent vasodilation in humans: role of endothelium-dependent nitric oxide and oxidative stress. Circulation. 2003 Aug 5;108(5):530-5. doi: 10.1161/01.CIR.0000080893.55729.28. Epub 2003 Jul 21.

  PMID: 12874192 BACKGROUND

• Yang MH, Kang SY, Lee JA, Kim YS, Sung EJ, Lee KY, Kim JS, Oh HJ, Kang HC, Lee SY. The Effect of Lifestyle Changes on Blood Pressure Control among Hypertensive Patients. Korean J Fam Med. 2017 Jul;38(4):173-180. doi: 10.4082/kjfm.2017.38.4.173. Epub 2017 Jul 20.

  PMID: 28775806 BACKGROUND

• Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.

  PMID: 17478161 BACKGROUND

• Colish J, Walker JR, Elmayergi N, Almutairi S, Alharbi F, Lytwyn M, Francis A, Bohonis S, Zeglinski M, Kirkpatrick IDC, Sharma S, Jassal DS. Obstructive sleep apnea: effects of continuous positive airway pressure on cardiac remodeling as assessed by cardiac biomarkers, echocardiography, and cardiac MRI. Chest. 2012 Mar;141(3):674-681. doi: 10.1378/chest.11-0615. Epub 2011 Aug 11.

  PMID: 21835901 BACKGROUND

• Patel D, Mohanty P, Di Biase L, Shaheen M, Lewis WR, Quan K, Cummings JE, Wang P, Al-Ahmad A, Venkatraman P, Nashawati E, Lakkireddy D, Schweikert R, Horton R, Sanchez J, Gallinghouse J, Hao S, Beheiry S, Cardinal DS, Zagrodzky J, Canby R, Bailey S, Burkhardt JD, Natale A. Safety and efficacy of pulmonary vein antral isolation in patients with obstructive sleep apnea: the impact of continuous positive airway pressure. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):445-51. doi: 10.1161/CIRCEP.109.858381. Epub 2010 Aug 5.

  PMID: 20689107 BACKGROUND

• Fein AS, Shvilkin A, Shah D, Haffajee CI, Das S, Kumar K, Kramer DB, Zimetbaum PJ, Buxton AE, Josephson ME, Anter E. Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation. J Am Coll Cardiol. 2013 Jul 23;62(4):300-5. doi: 10.1016/j.jacc.2013.03.052. Epub 2013 Apr 23.

  PMID: 23623910 BACKGROUND

• Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Imran SA, Rabasa-Lhoret R, Ross S. Targets for glycemic control. Can J Diabetes. 2013 Apr;37 Suppl 1:S31-4. doi: 10.1016/j.jcjd.2013.01.016. Epub 2013 Mar 26. No abstract available.

  PMID: 24070959 BACKGROUND

• Parekh PJ, Balart LA, Johnson DA. The Influence of the Gut Microbiome on Obesity, Metabolic Syndrome and Gastrointestinal Disease. Clin Transl Gastroenterol. 2015 Jun 18;6(6):e91. doi: 10.1038/ctg.2015.16.

  PMID: 26087059 BACKGROUND

• Di Daniele N, Noce A, Vidiri MF, Moriconi E, Marrone G, Annicchiarico-Petruzzelli M, D'Urso G, Tesauro M, Rovella V, De Lorenzo A. Impact of Mediterranean diet on metabolic syndrome, cancer and longevity. Oncotarget. 2017 Jan 31;8(5):8947-8979. doi: 10.18632/oncotarget.13553.

  PMID: 27894098 BACKGROUND

• International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2. Westchester: American Academy of Sleep Medicine; 2005

  BACKGROUND

• Harvard Medical School Special Health Reports. (2015). Starting to Exercise. by L. Howard Hartley, I-Min Lee, Harvard Health Publications.

  BACKGROUND

Related Links

• Implantable Loop Recorder description from the Mayo Clinic

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benedict M Glover, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Christopher Simpson, MD

  Queen's Unviersity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Simpson, MD

CONTACT

6135496666; simpsonc@kgh.kari.net

Milena A Bullen, BScH

CONTACT

6135496666; 12mb98@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data downloaded from the participants' implantable loop recorders will not be available to the investigators nor anyone involved in direct patient interaction in the study. A blinded event committee composed of three physicians with a specialization in cardiology, who are not directly involved in the research study, will have access to this data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Chief of Cardiac Arrhythmia Service, Department of Medicine

Model Details: A randomization schedule will be prepared by the data coordinating centre at Queen's University, Kingston, Ontario using a computerized random number-generator. Random allocation will be determined by a patient randomization software application. Participants will be randomized on a 1:1 fashion between active intervention and control.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 24, 2018
• Study Start: October 29, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

CA (1)