Arrhythmias, CardiacSMURFNCT01553045
Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation
An observational study of Arrhythmias, Cardiac and Heart Failure, Systolic, run by University Hospital, Linkoeping at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Heart Failure, Systolic, Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for catheter ablation of atrial fibrillation for the first time.
Who may be able to join
- 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.
Who cannot join
- Previous ablation attempts (surgical or catheter ablation)
- Unstable coronary disease
- Heart failure (NYHA III-IV)
- Sub-study:
- Same exclusion criteria as the main study
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Keywords
- symptom burden, atrial fibrillation, biomarkers, intracardiac pressures
- Medical subject headings
- Arrhythmias, Cardiac, Heart Failure, Systolic, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation, catheter ablation | Patients referred for ablation of atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 3 years
Levels of copeptin and MR-proADM in different sites of the heart and the effect of radiofrequency ablation
Measured: 3 years
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.
Measured: 3 years
The effect of radiofrequency ablation on the left atrial and left atrial appendix function
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Walfridsson, University Hospital, Linkoeping
- Investigators
- Anna Stromberg, Prof, R.N., Principal investigator, IMH, Dept of Medical and Health Sciences, Linkoping UniversityUrban Alehagen, Ass prof, MD, Principal investigator, IMH, Department of Medical and Health Sciences, Linkoping UniversityFredrik Nystrom, Prof, M.D., Principal investigator, IMH, Department of Medical and Health Sciences, Linkoping UniversityEva Nylander, Prof, M.D., Principal investigator, IMH, Department of Medical and Health Sciences, Linkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553045
- Sponsor's protocol ID
- SMURF
- Acronym
- SMURF
- Status last verified
- Dec 2014
- First submitted
- 2 Feb 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Almroth H, Karlsson LO, Carlhall CJ, Charitakis E. Haemodynamic changes after atrial fibrillation initiation in patients eligible for catheter ablation: a randomized controlled study. Eur Heart J Open. 2023 Oct 31;3(6):oead112. doi: 10.1093/ehjopen/oead112. eCollection 2023 Nov.
PubMed 38025650Charitakis 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.
PubMed 31632285Charitakis 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.
PubMed 29759606Charitakis 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.
PubMed 27956398Charitakis 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.
PubMed 27633393Charitakis 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.
PubMed 26692555
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01553045
- Acronym / sponsor ID
- SMURF / SMURF
- Keywords
- symptom burden, atrial fibrillation, biomarkers, intracardiac pressures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation, catheter ablation | – | –Patients referred for ablation of atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for catheter ablation of atrial fibrillation for the first time.
Key inclusion criteria (6 listed)
- Persistent or paroxysmal atrial fibrillation
- Symptoms of atrial fibrillation
- Referred for catheter ablation
- Same inclusion criteria as the main study plus
- -Freedom from arrhythmia the last four days before radiofrequency ablation.
Key exclusion criteria (5 listed)
- Previous ablation attempts (surgical or catheter ablation)
- Unstable coronary disease
- Heart failure (NYHA III-IV)
- Same exclusion criteria as the main study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom burden vs. peptide markers for heart failure
Time frame: 3 years
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
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.
6 secondary outcomes
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
Levels of copeptin and MR-proADM in different sites of the heart and the effect of radiofrequency ablation
Time frame: 3 years
The relation between left atrial function and neurohormonal activation in patients with atrial fibrillation eligible for radio frequency ablation
Time frame: 3 years
The effect of radiofrequency ablation on the left atrial and left atrial appendix function
Time frame: 3 years
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 38025650Almroth H, Karlsson LO, Carlhall CJ, Charitakis E. Haemodynamic changes after atrial fibrillation initiation in patients eligible for catheter ablation: a randomized controlled study. Eur Heart J Open. 2023 Oct 31;3(6):oead112. doi: 10.1093/ehjopen/oead112. eCollection 2023 Nov.
- Derived from this study: PubMed 31632285Charitakis 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.
- Derived from this study: PubMed 29759606Charitakis 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.
- Derived from this study: PubMed 27956398Charitakis 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.
- Derived from this study: PubMed 27633393Charitakis 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.
- Derived from this study: PubMed 26692555Charitakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Stromberg, Prof, R.N. principal investigator
IMH, Dept of Medical and Health Sciences, Linkoping University
Urban Alehagen, Ass prof, MD principal investigator
IMH, Department of Medical and Health Sciences, Linkoping University
Fredrik Nystrom, Prof, M.D. principal investigator
IMH, Department of Medical and Health Sciences, Linkoping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Heart Failure, Systolic, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom burden vs. peptide markers for heart failure (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553045, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.