Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation
NCT ID: NCT01553045
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2011-11-30
2015-06-30
Brief Summary
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The investigators aim to find correlations between symptom burden and intracardiac pressure, biomarkers and findings with echocardiography in order to find alternative means of treatment.
It is even intended to study the neurohormonal activation directly after the atrial fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.
Detailed Description
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It is known that B-type natriuretic peptide (BNP) and atrial natriuretic peptide (ANP) is stored in nodules in the atrial and ventricular myocytes and is produced in response to increased 'afterload' and 'preload' to restore and maintain cardiovascular homeostasis. Vasopressin (AVP), a non-cardiac plasma marker of cardiovascular disease, is released from the neurohypophysis in response to changes in plasma osmolality and is involved in osmoregulation and cardiovascular homeostasis. Adrenomodullin originates primarily in endothelial cells where cellular stress, ischaemia and hypoxia result in an increased production.
It is well-known that the concentrations of the natriuretic peptides are elevated in patients with AF and that the plasma concentrations decreased after conversion to sinus rhythm (SR). Yet their reaction when AF initiates is totally unknown. Moreover the role of ADM and AVP-hormonal system has not been researched in this category of patients.
Patients scheduled for catheter ablation of AF for the first time will be included; all with symptoms varying from moderate to severe. Using four health related quality of life forms the impact of AF on symptoms will be evaluated. Patients will be investigated with echocardiography, invasive hemodynamics and measurement of the levels of peptide indicators of heart failure and/or impact on myocardial function. Patients will also be categorized according to metabolic profile.
The information on this subject is scarce. Hemodynamic data is old and not correlated to symptoms. Effective and validated means of measuring health related quality of life including symptoms burden are relatively new tools. The aim is to find correlations between the impact on health related quality of life and parameters from echocardiographic measurements, from analysis of biomarkers (peptides) and from analysis of the metabolic profile.
In order to study the response of these four different neurohormonal systems (represented by NT-proBNP, MR-proANP, MR-proADM, copeptin) after the initiation of AF, a randomized interventional clinical sub-study is to be performed where the eligible population of SMURF main study can be randomized to AF induction or to control if freedom from AF is confirmed with thumb-ecg during the last 4 days before ablation. 45 patients are to be included to the sub-study with 2:1 allocation ratio with simple randomization.
If such correlations can be found alternate means for symptoms relief in AF patients can be identified and further ahead implemented in general health care.
The sub-study can give us a better insight on the AF initiation and the activation of different neurohormonal systems, an areas which is not well investigated.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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atrial fibrillation, catheter ablation
Patients referred for ablation of atrial fibrillation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Symptoms of atrial fibrillation
* Referred for catheter ablation
Sub-study:
-Freedom from arrhythmia the last four days before radiofrequency ablation.
Exclusion Criteria
* Unstable coronary disease
* Heart failure (NYHA III-IV)
Sub-study:
18 Years
ALL
No
Sponsors
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University Hospital, Linkoeping
OTHER
Responsible Party
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Hakan Walfridsson
Associate professor, M.D.
Principal Investigators
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Anna Stromberg, Prof, R.N.
Role: PRINCIPAL_INVESTIGATOR
IMH, Dept of Medical and Health Sciences, Linkoping University
Urban Alehagen, Ass prof, MD
Role: PRINCIPAL_INVESTIGATOR
IMH, Department of Medical and Health Sciences, Linkoping University
Fredrik Nystrom, Prof, M.D.
Role: PRINCIPAL_INVESTIGATOR
IMH, Department of Medical and Health Sciences, Linkoping University
Eva Nylander, Prof, M.D.
Role: PRINCIPAL_INVESTIGATOR
IMH, Department of Medical and Health Sciences, Linkoping University
Locations
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Dept of Cardiology, University Hospital
Linköping, , Sweden
Countries
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References
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Almroth H, Karlsson LO, Carlhall CJ, Charitakis E. Haemodynamic changes after atrial fibrillation initiation in patients eligible for catheter ablation: a randomized controlled study. Eur Heart J Open. 2023 Oct 31;3(6):oead112. doi: 10.1093/ehjopen/oead112. eCollection 2023 Nov.
Charitakis E, Karlsson LO, Papageorgiou JM, Walfridsson U, Carlhall CJ. Echocardiographic and Biochemical Factors Predicting Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation-An Observational Study. Front Physiol. 2019 Oct 2;10:1215. doi: 10.3389/fphys.2019.01215. eCollection 2019.
Charitakis E, Barmano N, Walfridsson U, Walfridsson H. Factors Predicting Arrhythmia-Related Symptoms and Health-Related Quality of Life in Patients Referred for Radiofrequency Ablation of Atrial Fibrillation: An Observational Study (the SMURF Study). JACC Clin Electrophysiol. 2017 May;3(5):494-502. doi: 10.1016/j.jacep.2016.12.004. Epub 2017 Mar 1.
Charitakis E, Walfridsson H, Nylander E, Alehagen U. Neurohormonal Activation After Atrial Fibrillation Initiation in Patients Eligible for Catheter Ablation: A Randomized Controlled Study. J Am Heart Assoc. 2016 Dec 12;5(12):e003957. doi: 10.1161/JAHA.116.003957.
Charitakis E, Walfridsson H, Alehagen U. Short-Term Influence of Radiofrequency Ablation on NT-proBNP, MR-proANP, Copeptin, and MR-proADM in Patients With Atrial Fibrillation: Data From the Observational SMURF Study. J Am Heart Assoc. 2016 Sep 15;5(9):e003557. doi: 10.1161/JAHA.116.003557.
Charitakis E, Walfridsson U, Nystrom F, Nylander E, Stromberg A, Alehagen U, Walfridsson H. 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. BMJ Open. 2015 Dec 21;5(12):e008723. doi: 10.1136/bmjopen-2015-008723.
Other Identifiers
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SMURF
Identifier Type: -
Identifier Source: org_study_id