Atrial FibrillationNCT04987723
A Mechanistic Exploratory Study of AF-induced Cardiac Dysfunction and Symptoms
A study testing Holter monitoring, stress echocardiography and Cardiac MRI in people with Atrial Fibrillation and Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Although the heart rhythm disorder Atrial Fibrillation (AF) affects 2% of the population, the impact it has on an effected individual can be highly variable. Some people are asymptomatic whilst others can experience debilitating symptoms or heart failure (HF)- weakness of the heart muscle. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Holter monitoring, stress echocardiography and Cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2022to 31 Oct 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for first AFCA procedure by their responsible physician.
- Persistent AF captured on ECG but not in continuous AF for more than 3 years. (Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.)
- Participants must have either:
- Left Ventricular Ejection Fraction (LVEF) < 50% by echocardiogram during routine screening or within 12 months prior to enrolment day. The echo must have been performed >3 weeks after optimisation of HF and rate control therapies, otherwise repeat imaging will be performed after this has been achieved
- With:
- o NYHA functional status II-III at the enrolment visit.
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- Or:
- o Left Ventricular Ejection Fraction (LVEF) >50% by echocardiogram during routine screening or within 12 months prior to enrolment day.
- With:
- o modified European Heart Rhythm Association 2a-4.
Who cannot join
- Previous left atrial ablation procedure or surgery.
- Contraindication to chronic anticoagulation therapy or heparin
- Unable or unwilling to consent to investigation and follow-up requirements or inability to comply with planned study procedures.
- LA anteroposterior diameter ≥ 5.5 cm or indexed LA volume ≥ 50mL/m2 on echo.
- Recent (last 6 months) event that may impact LV function- myocardial infarction, coronary revascularization, pacemaker or cardiac resynchronization therapy.
- AF suspected to be due to a reversible cause (e.g. hyperthyroidism, recent surgery)
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- Acute coronary syndrome within 4 weeks as defined by ECG ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
- Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrolment.
- Life expectancy less than 1 year.
- Chronic kidney disease stage 4 or 5.
- Any of the below cardiac diagnoses:
- Hypertrophic obstructive cardiomyopathy
- Severe valvular disease
- Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis,
- haemochromatosis
- Complex congenital heart disease
- Constrictive pericarditis
- Severe pulmonary hypertension (RVSP > 60 mmHg),
- Non-cardiac pulmonary oedema
- Active myocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Although the heart rhythm disorder Atrial Fibrillation (AF) affects 2% of the population, the impact it has on an effected individual can be highly variable. Some people are asymptomatic whilst others can experience debilitating symptoms or heart failure (HF)- weakness of the heart muscle. The reason why this variability exists in unknown and how AF actually drives HF is unclear. HF can also be caused by many other reasons and it can be difficult to identify those patients with HF caused by AF versus patients with AF but their HF is due to a different reason. This is important as it would help us to identify those patients most likely to improve their heart function after the treatment of AF and thus gain more from invasive treatments like AF catheter ablation; which is effective at restoring normal heart rhythm but has some risks attached.
The investigators suspect the characteristics of the AF, such as how irregularly it makes the heartbeat, can be used to predict who will respond better. Studies of heart cells in the lab as well as animal models have suggested this characteristic may be the cause of AF-induced heart muscle weakness and reduce cardiac output, making it a potential predictor that can be measured. Other potential predictors will be measured during pre-procedural scans and tests too. The investigators will also explore whether there are predictors of which patients gain the most symptomatic benefit and gain insight into why some people develop symptoms of AF, whereas others do not.
By studying the structural and functional sequelae of catheter ablation in patients with HF the investigators hope to better understand the relationship between the two diseases.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Holter monitoring, stress echocardiography, Cardiac MRI, Patient questionnaires
- Keywords
- atrial fibrillation, heart failure
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitoringOther
Also called Heart rate variability recording
Assessment of HRV shall be performed in all enrolled patients. Ventricular HRV will be derived from a continuous 24-hour period of a 48-hour ambulatory Holter recording during AF. Participants will be requested to avoid alcohol and caffeine from 24-hours prior to fitting and any activity more strenuous than walking for the recording duration. After initial fitting, a 20-minute high-resolution ECG recording will be performed lying supine at rest.
stress echocardiographyOther
Also called assessment of cardiac reserve
Echocardiography will be performed using a GE Vivid 9 echocardiography machine (Vingmed-General Electric, Horten, Norway) equipped with a phased-array 3.5 MHz transducer. All measurements will be made according to the guidelines set by the British Society of Echocardiography.
Cardiac MRIOther
Contraindications to MRI will be excluded using the appropriate departmental screening forms. A trained scanner operator or radiographer will co-ordinate and supervise the scan. Cardiac MRI will be performed at 1.5T (Aera, Siemens Healthineers, Erlangen, Germany) with a protocol consisting of cine imaging, stress and rest perfusion, and late gadolinium enhancement (LGE).
Patient questionnairesOther
Also called AFeQT questionnaire and the Barts AF PROM questionnaire
Two validated Health Related Quality of Life (HRQoL) surveys designed for patients with AF will be used; the AF Effect on Quality of Life (AFEQT) and Barts AF Patient reported objective measure (PROM).
| Study group | Role | What they receive |
|---|---|---|
| AF + HFrEF cohort | Other | Left Ventricular Ejection Fraction (LVEF) < 50% by echocardiogram during routine screening or within 12 months prior to enrolment day. The echo must have been performed >3 weeks after optimisation of HF and rate control therapies, otherwise repeat imaging will be performed after this has been achieved
With
NYHA functional status II-III at the enrolment visit. Receives: Other: Holter monitoring; Other: stress echocardiography; Other: Cardiac MRI; Other: Patient questionnaires |
| AF + symptoms cohort | Other | Left Ventricular Ejection Fraction (LVEF) > 50% by echocardiogram during routine screening or within 12 months prior to enrolment day
With
modified European Heart Rhythm Association symptom classification 2b-4. Receives: Other: Holter monitoring; Other: Patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation co-efficient of HRV measures with change in cardiac function
This will be calculated in the AF + HFreF arm
Cardiac function will be measured as three endpoints:
- LVEF on echocardiography
- Serum NT-proBNP
- VO2 peak on CPET
Measured: 6 months after catheter ablation
Secondary outcomes (2)
Correlation co-efficient of LA strain with change in cardiac function
This will be calculated in the AF + HFreF arm
Cardiac function will be measured as three endpoints:
- LVEF on echocardiography
- Serum NT-proBNP
- VO2 peak on CPET
Measured: 6 months after catheter ablation
Correlation co-efficient of HRV measures with change in score on validated AF PROM questionnaire
This will be calculated for each study arm independently. The scores from the
- AFeQT survey
- Barts AF PROM survey will be used
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start21 Jan 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Schilling, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987723
- Sponsor's protocol ID
- 272775
- Status last verified
- Feb 2025
- First submitted
- 14 Jul 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunter RJ, Berriman TJ, Diab I, Kamdar R, Richmond L, Baker V, Goromonzi F, Sawhney V, Duncan E, Page SP, Ullah W, Unsworth B, Mayet J, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):31-8. doi: 10.1161/CIRCEP.113.000806. Epub 2014 Jan 1.
PubMed 24382410Ahluwalia N, Honarbakhsh S, Abbass H, Joshi A, Chow AWC, Dhinoja M, Petersen SE, Hunter RJ, Lloyd G, Schilling RJ. Characterisation of patients who develop atrial fibrillation-induced cardiomyopathy. Open Heart. 2024 Nov 27;11(2):e002955. doi: 10.1136/openhrt-2024-002955.
PubMed 39608861
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Exploratory Study of AF-induced Cardiac Dysfunction and Symptoms
- ClinicalTrials.gov ID
- NCT04987723
- Acronym / sponsor ID
- 272775
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- atrial fibrillation, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 3 Aug 2021 (actual)
- 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.
Although the heart rhythm disorder Atrial Fibrillation (AF) affects 2% of the population, the impact it has on an effected individual can be highly variable. Some people are asymptomatic whilst others can experience debilitating symptoms or heart failure (HF)- weakness of the heart muscle. The reason why this variability exists in unknown and how AF actually drives HF is unclear. HF can also be caused by many other reasons and it can be difficult to identify those patients with HF caused by AF versus patients with AF but their HF is due to a different reason. This is important as it would help us to identify those patients most likely to improve their heart function after the treatment of AF and thus gain more from invasive treatments like AF catheter ablation; which is effective at restoring normal heart rhythm but has some risks attached.
The investigators suspect the characteristics of the AF, such as how irregularly it makes the heartbeat, can be used to predict who will respond better. Studies of heart cells in the lab as well as animal models have suggested this characteristic may be the cause of AF-induced heart muscle weakness and reduce cardiac output, making it a potential predictor that can be measured. Other potential predictors will be measured during pre-procedural scans and tests too. The investigators will also explore whether there are predictors of which patients gain the most symptomatic benefit and gain insight into why some people develop symptoms of AF, whereas others do not.
By studying the structural and functional sequelae of catheter ablation in patients with HF the investigators hope to better understand the relationship between the two diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF + HFrEF cohort | Other | Other: Holter monitoring, Other: stress echocardiography, Other: Cardiac MRI, Other: Patient questionnairesLeft Ventricular Ejection Fraction (LVEF) < 50% by echocardiogram during routine screening or within 12 months prior to enrolment day. The echo must have been performed >3 weeks after optimisation of HF and rate control therapies, otherwise repeat imaging will be performed after this has been achieved With NYHA functional status II-III at the enrolment visit. |
| AF + symptoms cohort | Other | Other: Holter monitoring, Other: Patient questionnairesLeft Ventricular Ejection Fraction (LVEF) > 50% by echocardiogram during routine screening or within 12 months prior to enrolment day With modified European Heart Rhythm Association symptom classification 2b-4. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Referred for first AFCA procedure by their responsible physician.
- Persistent AF captured on ECG but not in continuous AF for more than 3 years. (Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.)
- Participants must have either:
- o NYHA functional status II-III at the enrolment visit.
- o Left Ventricular Ejection Fraction (LVEF) >50% by echocardiogram during routine screening or within 12 months prior to enrolment day.
Key exclusion criteria (20 listed)
- Previous left atrial ablation procedure or surgery.
- Contraindication to chronic anticoagulation therapy or heparin
- Unable or unwilling to consent to investigation and follow-up requirements or inability to comply with planned study procedures.
- LA anteroposterior diameter ≥ 5.5 cm or indexed LA volume ≥ 50mL/m2 on echo.
- Recent (last 6 months) event that may impact LV function- myocardial infarction, coronary revascularization, pacemaker or cardiac resynchronization therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter monitoringAlso: Heart rate variability recordingAssessment of HRV shall be performed in all enrolled patients. Ventricular HRV will be derived from a continuous 24-hour period of a 48-hour ambulatory Holter recording during AF. Participants will be requested to avoid alcohol and caffeine from 24-hours prior to fitting and any activity more strenuous than walking for the recording duration. After initial fitting, a 20-minute high-resolution ECG recording will be performed lying supine at rest. | Other | AF + HFrEF cohort, AF + symptoms cohort |
| stress echocardiographyAlso: assessment of cardiac reserveEchocardiography will be performed using a GE Vivid 9 echocardiography machine (Vingmed-General Electric, Horten, Norway) equipped with a phased-array 3.5 MHz transducer. All measurements will be made according to the guidelines set by the British Society of Echocardiography. | Other | AF + HFrEF cohort |
| Cardiac MRIContraindications to MRI will be excluded using the appropriate departmental screening forms. A trained scanner operator or radiographer will co-ordinate and supervise the scan. Cardiac MRI will be performed at 1.5T (Aera, Siemens Healthineers, Erlangen, Germany) with a protocol consisting of cine imaging, stress and rest perfusion, and late gadolinium enhancement (LGE). | Other | AF + HFrEF cohort |
| Patient questionnairesAlso: AFeQT questionnaire and the Barts AF PROM questionnaireTwo validated Health Related Quality of Life (HRQoL) surveys designed for patients with AF will be used; the AF Effect on Quality of Life (AFEQT) and Barts AF Patient reported objective measure (PROM). | Other | AF + HFrEF cohort, AF + symptoms cohort |
Primary outcome
Correlation co-efficient of HRV measures with change in cardiac function
Time frame: 6 months after catheter ablation
This will be calculated in the AF + HFreF arm Cardiac function will be measured as three endpoints: * LVEF on echocardiography * Serum NT-proBNP * VO2 peak on CPET
2 secondary outcomes
Correlation co-efficient of LA strain with change in cardiac function
Time frame: 6 months after catheter ablation
Correlation co-efficient of HRV measures with change in score on validated AF PROM questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 24382410Hunter RJ, Berriman TJ, Diab I, Kamdar R, Richmond L, Baker V, Goromonzi F, Sawhney V, Duncan E, Page SP, Ullah W, Unsworth B, Mayet J, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):31-8. doi: 10.1161/CIRCEP.113.000806. Epub 2014 Jan 1.
- Derived from this study: PubMed 39608861Ahluwalia N, Honarbakhsh S, Abbass H, Joshi A, Chow AWC, Dhinoja M, Petersen SE, Hunter RJ, Lloyd G, Schilling RJ. Characterisation of patients who develop atrial fibrillation-induced cardiomyopathy. Open Heart. 2024 Nov 27;11(2):e002955. doi: 10.1136/openhrt-2024-002955.
- Individual participant dataSharing planned: No
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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.
Richard Schilling principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter monitoring, stress echocardiography and Cardiac MRI in people with Atrial Fibrillation and Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 10 Feb 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation co-efficient of HRV measures with change in cardiac function (time frame: 6 months after catheter ablation). 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 NCT04987723, which also lists 2 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 10 Feb 2025.