Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation (SMURF)

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Hakan Walfridsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01553045
First received: February 2, 2012
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition
Arrhythmias, Cardiac
Heart Failure, Systolic
Atrial Fibrillation

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
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)
Groups/Cohorts
atrial fibrillation, catheter ablation
Patients referred for ablation of atrial fibrillation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred for catheter ablation of atrial fibrillation for the first time.

Criteria

Inclusion Criteria:

  • Persistent or paroxysmal atrial fibrillation
  • Symptoms of atrial fibrillation
  • Referred for catheter ablation

Exclusion Criteria:

  • Previous ablation attempts (surgical or catheter ablation)
  • Unstable coronary disease
  • Heart failure (NYHA III-IV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553045

Contacts
Contact: Hakan Walfridsson, M.D.Ph.D. +46 10 1032199 hakan.walfridsson@lio.se
Contact: Emmanouil Charitakis, M.D. +46 10 1030000 Emmanouil.Charitakis@lio.se

Locations
Sweden
Dept of Cardiology, University Hospital Recruiting
Linkoeping, Sweden, SE58185
Contact: Hakan Walfridsson, M.D.Ph.D.     +46101031000 ext 32199     hakan.walfridsson@lio.se    
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.            
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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
  More Information

No publications provided

Responsible Party: Hakan Walfridsson, Associate professor, M.D., University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01553045     History of Changes
Other Study ID Numbers: SMURF
Study First Received: February 2, 2012
Last Updated: June 11, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
symptom burden
atrial fibrillation
biomarkers
intracardiac pressures

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013