- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01553045
Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation (SMURF)
Observational Study of the Variation in Health-related Quality of Life and Symptom Burden in Patients Accepted for Catheter Ablation of Atrial Fibrillation in Relation to Biomarkers, Intracardiac Pressures and Echocardiography.
Atrial fibrillation is the most common cardiac arrhythmia. There is a large variation in symptoms; from almost none to severe but the reason for this is unclear.
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Atrial fibrillation (AF) is the most common cardiac arrhythmia and more than 1 % of the population suffers from AF, it is an independent risk factor for ischemic stroke One major unresolved issue concerning AF is the large variety in symptoms. In some AF is diagnosed accidentally while in others symptoms are severe and disabling.
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
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Linkoeping, Ruotsi, SE58185
- Dept of Cardiology, University Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Persistent or paroxysmal atrial fibrillation
- Symptoms of atrial fibrillation
- Referred for catheter ablation
Sub-study:
Same inclusion criteria as the main study plus
-Freedom from arrhythmia the last four days before radiofrequency ablation.
Exclusion Criteria:
- Previous ablation attempts (surgical or catheter ablation)
- Unstable coronary disease
- Heart failure (NYHA III-IV)
Sub-study:
Same exclusion criteria as the main study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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atrial fibrillation, catheter ablation
Patients referred for ablation of atrial fibrillation
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Symptom burden vs. peptide markers for heart failure
Aikaikkuna: 3 years
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Health related quality of life (HRQOL)and arrhythmia symptom burden vill be evaluated and related to the level of four different peptides: NT-pro-BNP, Copeptin, MR-pro-ADM and MR-pro-AMP. HRQOL will be measured with the aid of Short-Form-36 (SF-36) and an arrhythmia specific questionnaire containing two parts: One part evaluating symptoms and another part evaluating HRQOL. Both parts are validated and compared to "Symptoms Checklist, Frequency and Severity Scale" and SF-36, respectively. |
3 years
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Sub-study primary outcome: Levels of four biomarkers in relation to heart rhythm
Aikaikkuna: 3 years
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The following biomarkers will be evaluated during sinus rhythm and after at least 30 min of induced atrial fibrillation: NT-pro-BNP, Copeptin, MR-pro-ADM and MR-pro-AMP.
These biomarkers will also be measured 24 hours after ablation and at follow-up after three months.
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3 years
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Levels of NT-proBNP and MR-proANP in different sites of the heart and the effect of radiofrequency ablation in relation to heart rhythm
Aikaikkuna: 3 years
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The level of the following biomarkers will be evaluated: NT-pro-BNP, Copeptin, MR-pro-ADM and MR-pro-AMP.
These biomarkers will also be measured 24 hours after ablation and at follow-up after three months.
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3 years
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Levels of copeptin and MR-proADM in different sites of the heart and the effect of radiofrequency ablation
Aikaikkuna: 3 years
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3 years
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The relation between left atrial function and neurohormonal activation in patients with atrial fibrillation eligible for radio frequency ablation
Aikaikkuna: 3 years
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The left atrial function is to be echocardiographically accessed.
LA volumes , ejection fraction but even 2D strain and strain rate of the left atrium are to be measured.
Left ventricular function and left atrial appendix function are also to be studied.
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3 years
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The effect of radiofrequency ablation on the left atrial and left atrial appendix function
Aikaikkuna: 3 years
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3 years
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Alcohol consumption in a atrial fibrillation population undergoing radio frequency ablation (RFA), the connection between alcohol consumption and quality of life and arrhythmia freedom after RFA
Aikaikkuna: 3 years
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Analysis of ethyl glucuronide in hair samples of the patients is to be done in order to access the level of alcohol consumption
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3 years
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Which factors influence the quality of life in patients with atrial fibrillation (AF) undergoing ablation. Do patients with more symptoms have a greater activation of neurohormonal systems and increase of intracardiac pressures after the initiation of AF
Aikaikkuna: 3 years
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3 years
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Anna Stromberg, Prof, R.N., IMH, Dept of Medical and Health Sciences, Linkoping University
- Päätutkija: Urban Alehagen, Ass prof, MD, IMH, Department of Medical and Health Sciences, Linkoping University
- Päätutkija: Fredrik Nystrom, Prof, M.D., IMH, Department of Medical and Health Sciences, Linkoping University
- Päätutkija: Eva Nylander, Prof, M.D., IMH, Department of Medical and Health Sciences, Linkoping University
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SMURF
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