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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 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: May 30, 2013
Last verified: May 2013
  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.

It is even intended to study the neurohormonal activation directly after the atrial fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.


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 Severity Scale" and SF-36, respectively.


  • Sub-study primary outcome: Levels of four biomarkers in relation to heart rhythm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Levels of NT-proBNP and MR-proANP in different sites of the heart and the effect of radiofrequency ablation in relation to heart rhythm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Levels of copeptin and MR-proADM in different sites of the heart and the effect of radiofrequency ablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The relation between left atrial function and neurohormonal activation in patients with atrial fibrillation eligible for radio frequency ablation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • The effect of radiofrequency ablation on the left atrial and left atrial appendix function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Analysis of ethyl glucuronide in hair samples of the patients is to be done in order to access the level of alcohol consumption

  • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples will be drawn from femoral vein, CS and LA (baseline sampling).

Concerning sub-study: After the induction of AF and after the patient has maintained AF in 30 minutes blood samples will be drawn in the exact same way as before the induction in the intervention group.

Patients who are going to be randomized to control group after the baseline blood sampling, are going to be monitored in about 30 minutes to examine whether they maintain sinus rhythm (SR) under that time. No intervention, clinical or experimental is going to be made during that time. After those 30 minutes, blood samples are going to be drawn in the exact same way as before.

Blood to be analyzed for biomarkers will be froozen to -70 degress and analyzed when the study is completed.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (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.

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.

  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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 30, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014