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

Atrial Fibrillation Clinical Trial

— SMURF  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01553045
• Other study ID #: SMURF
• Status: Active, not recruiting
• Phase: N/A
• First received: February 2, 2012
• Last updated: December 2, 2014
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Heart Failure, Systolic

Locations

Country	Name	City	State
Sweden	Dept of Cardiology, University Hospital	Linkoeping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom burden vs. peptide markers for heart failure	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	No
Primary	Sub-study primary outcome: Levels of four biomarkers in relation to heart rhythm	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.	3 years	No
Secondary	Levels of NT-proBNP and MR-proANP in different sites of the heart and the effect of radiofrequency ablation in relation to heart rhythm	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.	3 years	No
Secondary	Levels of copeptin and MR-proADM in different sites of the heart and the effect of radiofrequency ablation		3 years	No
Secondary	The relation between left atrial function and neurohormonal activation in patients with atrial fibrillation eligible for radio frequency ablation	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.	3 years	No
Secondary	The effect of radiofrequency ablation on the left atrial and left atrial appendix function		3 years	No
Secondary	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	Analysis of ethyl glucuronide in hair samples of the patients is to be done in order to access the level of alcohol consumption	3 years	No
Secondary	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		3 years	No