Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation (SMURF)
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.
Heart Failure, Systolic
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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.|
- Symptom burden vs. peptide markers for heart failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 Severety Scale" and SF-36, respecively.
- Levels of four biomarkers in relation to heart rhythm [ Time Frame: 3 years ] [ Designated as safety issue: No ]The following biomarkers will be evealuated during sinusrhythm 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.
Biospecimen Retention: Samples Without DNA
Blood to be analyzed for biomarkers will be froozen to -70 degress and analyzed when the study is completed.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
atrial fibrillation, catheter ablation
Patients referred for ablation of atrial fibrillation
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.
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.
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.
|Contact: Hakan Walfridsson, M.D.Ph.D.||+46 10 email@example.com|
|Contact: Emmanouil Charitakis, M.D.||+46 10 1030000||Emmanouil.Charitakis@lio.se|
|Dept of Cardiology, University Hospital||Recruiting|
|Linkoeping, Sweden, SE58185|
|Contact: Hakan Walfridsson, M.D.Ph.D. +46101031000 ext 32199 firstname.lastname@example.org|
|Principal Investigator: Hakan Walfridsson, M.D.Ph.D.|
|Sub-Investigator: Emmanouil Charitakis, M.D.|
|Sub-Investigator: Urban Alehagen, M.D.Ph.D.|
|Sub-Investigator: Eva Nylander, M.D.Ph.D.|
|Sub-Investigator: Fredrik Nystoem, M.D.Ph.D.|
|Sub-Investigator: Anna Stroemberg, R.N.Ph.D.|
|Principal Investigator:||Anna Stromberg, Prof, R.N.||IMH, Dept of Medical and Health Sciences, Linkoping University|
|Principal Investigator:||Urban Alehagen, Ass prof, MD||IMH, Department of Medical and Health Sciences, Linkoping University|
|Principal Investigator:||Fredrik Nystrom, Prof, M.D.||IMH, Department of Medical and Health Sciences, Linkoping University|
|Principal Investigator:||Eva Nylander, Prof, M.D.||IMH, Department of Medical and Health Sciences, Linkoping University|