Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation (SMURF): a protocol for an observational study with a randomised interventional component

Emmanouil Charitakis, Ulla Walfridsson, Fredrik Nyström, Eva Nylander, Anna Strömberg, Urban Alehagen, Håkan Walfridsson, Emmanouil Charitakis, Ulla Walfridsson, Fredrik Nyström, Eva Nylander, Anna Strömberg, Urban Alehagen, Håkan Walfridsson

Abstract

Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1.5-2%. It is an independent risk factor for ischaemic stroke and is estimated to cause about 20-25% of all stroke cases. AF has a great impact on health-related quality of life (HRQoL); however, one unresolved issue related to AF is the wide variation in its symptoms.

Methods and analysis: The symptom burden, metabolic profile, ultrasound findings, rhythm, neurohormonal activation, haemodynamics and HRQoL in patients with AF (Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation, SMURF) study is a prospective observational, cohort study, with a randomised interventional part. The aim of the study is to investigate, in patients with AF, the relationship between symptom burden and metabolic aspects, atrial function and different neurohormones, and the effect of radiofrequency ablation (RFA). The interventional part of the study will give an insight into the neurohormonal and intracardiac pressure changes directly after initiation of AF. Consecutive patients with symptomatic AF accepted for treatment with RFA for the first time at Linköping University Hospital are eligible for participation. The enrolment started in January 2012, and a total of 200 patients are to be included into the study, with 45 of them being enrolled into the interventional study with initiation of AF. The sample size of the interventional study is based on a small pilot study with 5 patients induced to AF while 2 served as controls. The results indicated that, in order to find a statistically significant difference, there was a need to include 28 patients; for safety reasons, 45 patients will be included.

Ethics and dissemination: The SMURF study is approved by the Regional Ethical Review Board at the Faculty of Health Sciences, Linköping, Sweden. The results will be presented through peer-review journals and conference presentation.

Trial registration number: NCT01553045; Pre-results.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Enrolment and follow-up flow chart (AF, atrial fibrillation; HRQoL, health-related quality of life;RFA, radiofrequency ablation).
Figure 2
Figure 2
Eligibility and randomisation process in the interventional study (AF, atrial fibrillation).

References

    1. Camm AJ, Lip GY, De Caterina R et al. . 2012 Focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33:2719–47. 10.1093/eurheartj/ehs253
    1. Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med 2013;274:461–8. 10.1111/joim.12114
    1. Lin HJ, Wolf PA, Kelly-Hayes M et al. . Stroke severity in atrial fibrillation. The Framingham Study . Stroke 1996;27:1760–4. 10.1161/01.STR.27.10.1760
    1. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–8. 10.1161/01.STR.22.8.983
    1. Stewart S, Hart CL, Hole DJ et al. . A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med 2002;113:359–64. 10.1016/S0002-9343(02)01236-6
    1. Benjamin EJ, Wolf PA, D'Agostino RB et al. . Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 1998;98:946–52. 10.1161/01.CIR.98.10.946
    1. January CT, Wann LS, Alpert JS et al. . American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014;64:e1–76. 10.1016/j.jacc.2014.03.022
    1. Kodama S, Saito K, Tanaka S et al. . Alcohol consumption and risk of atrial fibrillation: a meta-analysis. J Am Coll Cardiol 2011;57:427–36. 10.1016/j.jacc.2010.08.641
    1. Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med 2004;164:1675–8. 10.1001/archinte.164.15.1675
    1. Kang Y. Relation of atrial arrhythmia-related symptoms to health-related quality of life in patients with newly diagnosed atrial fibrillation: a community hospital-based cohort. Heart Lung 2006;35:170–7. 10.1016/j.hrtlng.2006.01.002
    1. Thrall G, Lane D, Carroll D et al. . Quality of life in patients with atrial fibrillation: a systematic review. Am J Med 2006;119:448.e1–19. 10.1016/j.amjmed.2005.10.057
    1. Silberbauer J, Veasey RA, Cheek E et al. . Electrophysiological characteristics associated with symptoms in pacemaker patients with paroxysmal atrial fibrillation. J Interv Card Electrophysiol 2009;26:31–40. 10.1007/s10840-009-9411-x
    1. Steg PG, Alam S, Chiang CE et al. . Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry. Heart 2012;98:195–201. 10.1136/heartjnl-2011-300550
    1. Paquette M, Roy D, Talajic M et al. . Role of gender and personality on quality-of-life impairment in intermittent atrial fibrillation. Am J Cardiol 2000;86:764–8. 10.1016/S0002-9149(00)01077-8
    1. Son YJ, Song EK. The impact of type D personality and high-sensitivity C-reactive protein on health-related quality of life in patients with atrial fibrillation. Eur J Cardiovasc Nurs 2012;11:304–12. 10.1016/j.ejcnurse.2011.04.004
    1. Vyssoulis G, Karpanou E, Adamopoulos D et al. . Metabolic syndrome and atrial fibrillation in patients with essential hypertension. Nutr Metab Cardiovasc Dis 2013;23:109–14. 10.1016/j.numecd.2011.03.011
    1. Tanner RM, Baber U, Carson AP et al. . Association of the metabolic syndrome with atrial fibrillation among United States adults (from the REasons for Geographic and Racial Differences in Stroke [REGARDS] Study). Am J Cardiol 2011;108:227–32. 10.1016/j.amjcard.2011.03.026
    1. von Bibra H, St John Sutton M. Diastolic dysfunction in diabetes and the metabolic syndrome: promising potential for diagnosis and prognosis. Diabetologia 2010;53:1033–45. 10.1007/s00125-010-1682-3
    1. Shigematsu Y, Hamada M, Nagai T et al. . Risk for atrial fibrillation in patients with hypertrophic cardiomyopathy: association with insulin resistance. J Cardiol 2011;58:18–25. 10.1016/j.jjcc.2011.03.001
    1. Rich EC, Siebold C, Campion B. Alcohol-related acute atrial fibrillation. A case-control study and review of 40 patients. Arch Intern Med 1985;145:830–3. 10.1001/archinte.1985.00360050074012
    1. Corrao G, Rubbiati L, Bagnardi V et al. . Alcohol and coronary heart disease: a meta-analysis. Addiction 2000;95:1505–23. 10.1046/j.1360-0443.2000.951015056.x
    1. Samokhvalov AV, Irving HM, Rehm J. Alcohol consumption as a risk factor for atrial fibrillation: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil 2010;17:706–12. 10.1097/HJR.0b013e32833a1947
    1. Kronstrand R, Brinkhagen L, Nyström FH. Ethyl glucuronide in human hair after daily consumption of 16 or 32 g of ethanol for 3 months. Forensic Sci Int 2012;215:51–5. 10.1016/j.forsciint.2011.01.044
    1. Benjamin EJ, D'Agostino RB, Belanger AJ et al. . Left atrial size and the risk of stroke and death. The Framingham Heart Study. Circulation 1995;92:835–41. 10.1161/01.CIR.92.4.835
    1. Leitman M, Lysyansky P, Sidenko S et al. . Two-dimensional strain-a novel software for real-time quantitative echocardiographic assessment of myocardial function. J Am Soc Echocardiogr 2004;17:1021–9. 10.1016/j.echo.2004.06.019
    1. Langeland S, D'Hooge J, Wouters PF et al. . Experimental validation of a new ultrasound method for the simultaneous assessment of radial and longitudinal myocardial deformation independent of insonation angle. Circulation 2005;112:2157–62. 10.1161/CIRCULATIONAHA.105.554006
    1. Vianna-Pinton R, Moreno CA, Baxter CM et al. . Two-dimensional speckle-tracking echocardiography of the left atrium: feasibility and regional contraction and relaxation differences in normal subjects. J Am Soc Echocardiogr 2009;22:299–305. 10.1016/j.echo.2008.12.017
    1. Flynn TG, de Bold ML, de Bold AJ. The amino acid sequence of an atrial peptide with potent diuretic and natriuretic properties. Biochem Biophys Res Commun 1983;117:859–65. 10.1016/0006-291X(83)91675-3
    1. Goetze JP, Friis-Hansen L, Rehfeld JF et al. . Atrial secretion of B-type natriuretic peptide. Eur Heart J 2006;27:1648–50. 10.1093/eurheartj/ehl109
    1. Inoue S, Murakami Y, Sano K et al. . Atrium as a source of brain natriuretic polypeptide in patients with atrial fibrillation. J Card Fail 2000;6:92–6. 10.1016/S1071-9164(00)90010-1
    1. Yasue H, Yoshimura M, Sumida H et al. . Localization and mechanism of secretion of B-type natriuretic peptide in comparison with those of A-type natriuretic peptide in normal subjects and patients with heart failure. Circulation 1994;90:195–203. 10.1161/01.CIR.90.1.195
    1. Clerico A, Emdin M. Diagnostic accuracy and prognostic relevance of the measurement of cardiac natriuretic peptides: a review. Clin Chem 2004;50:33–50. 10.1373/clinchem.2003.024760
    1. Ellinor PT, Low AF, Patton KK et al. . Discordant atrial natriuretic peptide and brain natriuretic peptide levels in lone atrial fibrillation. J Am Coll Cardiol 2005;45:82–6. 10.1016/j.jacc.2004.09.045
    1. van den Berg MP, Tjeerdsma G, Jan de Kam P et al. . Longstanding atrial fibrillation causes depletion of atrial natriuretic peptide in patients with advanced congestive heart failure. Eur J Heart Fail 2002;4:255–62. 10.1016/S1388-9842(01)00232-X
    1. Wozakowska-Kaplon B. Effect of sinus rhythm restoration on plasma brain natriuretic peptide in patients with atrial fibrillation. Am J Cardiol 2004;93:1555–8. 10.1016/j.amjcard.2004.03.013
    1. Hijazi Z, Wallentin L, Siegbahn A et al. . N-terminal pro-B-type natriuretic peptide for risk assessment in patients with atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation). J Am Coll Cardiol 2013;61:2274–84. 10.1016/j.jacc.2012.11.082
    1. Morgenthaler NG, Struck J, Thomas B et al. . Immunoluminometric assay for the midregion of pro-atrial natriuretic peptide in human plasma. Clin Chem 2004;50:234–6. 10.1373/clinchem.2003.021204
    1. Chatterjee K. Neurohormonal activation in congestive heart failure and the role of vasopressin. Am J Cardiol 2005;95:8B–13B. 10.1016/j.amjcard.2005.03.003
    1. Voors AA, von Haehling S, Anker SD et al. . C-terminal provasopressin (copeptin) is a strong prognostic marker in patients with heart failure after an acute myocardial infarction: results from the OPTIMAAL study. Eur Heart J 2009;30:1187–94. 10.1093/eurheartj/ehp098
    1. Sugo S, Minamino N, Kangawa K et al. . Endothelial cells actively synthesize and secrete adrenomedullin. Biochem Biophys Res Commun 1994;201:1160–6. 10.1006/bbrc.1994.1827
    1. Bunton DC, Petrie MC, Hillier C et al. . The clinical relevance of adrenomedullin: a promising profile? Pharmacol Ther 2004;103:179–201. 10.1016/j.pharmthera.2004.07.002
    1. Morgenthaler NG, Struck J, Alonso C et al. . Measurement of midregional proadrenomedullin in plasma with an immunoluminometric assay. Clin Chem 2005;51:1823–9. 10.1373/clinchem.2005.051110
    1. [No authors listed] [The Helsinki Declaration of the World Medical Association (WMA). Ethical principles of medical research involving human subjects]. Pol Merkur Lekarski 2014;36:298–301.
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83. 10.1097/00005650-199206000-00002
    1. Ware JE Jr, McCrady SK, Kosinski M et al. . SF-36 health survey manual and interpretation guide. New England Medical Center, 1993.
    1. Walfridsson U, Walfridsson H, Arestedt K et al. . Impact of radiofrequency ablation on health-related quality of life in patients with paroxysmal supraventricular tachycardia compared with a norm population one year after treatment. Heart Lung 2011;40:405–11. 10.1016/j.hrtlng.2010.09.004
    1. Walfridsson U, Arestedt K, Stromberg A. Development and validation of a new Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) with focus on symptom burden. Health Qual Life Outcomes 2012;10:44 10.1186/1477-7525-10-44
    1. Walfridsson U, Strömberg A, Årestedt K. Development and validation of an arrhythmia-specific scale in tachycardia and arrhythmia with focus on health-related quality of life. J Cardiovascular Nurs 2015;30:98–108.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Bjelland I, Dahl AA, Haug TT et al. . The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002;52:69–77. 10.1016/S0022-3999(01)00296-3
    1. Moser DK, Dracup K. Psychosocial recovery from a cardiac event: the influence of perceived control. Heart Lung 1995;24:273–80. 10.1016/S0147-9563(05)80070-6
    1. Årestedt K, Ågren S, Flemme I et al. . A psychometric evaluation of the four-item version of the Control Attitudes Scale for patients with cardiac disease and their partners. Eur J Cardiovasc Nurs 2015;14:317–25. 10.1177/1474515114529685
    1. Hendrikx T, Rosenqvist M, Wester P et al. . Intermittent short ECG recording is more effective than 24-hour Holter ECG in detection of arrhythmias. BMC Cardiovasc Disord 2014;14:41 10.1186/1471-2261-14-41
    1. Doliwa Sobocinski P, Anggårdh Rooth E, Frykman Kull V et al. . Improved screening for silent atrial fibrillation after ischaemic stroke. Europace 2012;14:1112–16. 10.1093/europace/eur431
    1. Lang RM, Badano LP, Mor-Avi V et al. . Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2015;16:233–71. 10.1093/ehjci/jev014
    1. Sacher F, Corcuff JB, Schraub P et al. . Chronic atrial fibrillation ablation impact on endocrine and mechanical cardiac functions. Eur Heart J 2008;29:1290–5. 10.1093/eurheartj/ehm577
    1. Dietz JR. Mechanisms of atrial natriuretic peptide secretion from the atrium. Cardiovasc Res 2005;68:8–17. 10.1016/j.cardiores.2005.06.008

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe