CardiomyopathyNCT07574697
AIC Genotyping Study
An observational study of Cardiomyopathy and Atrial Fibrillation (AF), run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
To quantify genetic variants in a focused DCM gene panel among AF-induced cardiomyopathy (AIC) and positive/negative controls Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Atrial Fibrillation (AF), Genetic
- How many people
- 299 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population is patients with a diagnosis of persistent AF who have undergone AF CA. Their LVEF at baseline and after CA in Sinus rhythm will determine eligibility. Barts Heart Centre, based at St Bartholomew's Hospital is a tertiary referral centre for cardiac electrophysiology with established expertise in AF CA. This will be the single study site. The team performed approximately 1300 index procedure AF CAs in 2018. Referral for AF CA to Barts Heart Centre is through a 'hub and spoke' arrhythmia service delivery model with its surrounding hospitals. Patients will be referred to the CRF for screening from the Electrophysiology out-patients clinic alongside the referral for AF CA. Vulnerable groups shall be excluded from this study.
Who may be able to join
- AIC (Cases):
- Age ≥18
- Persistent AF before index catheter ablation or cardioversion
- LVEF ≤40% during rate-controlled (resting HR <100bpm, mean HR on 24-hour Holter <100bpm) AF prior to index catheter ablation or cardioversion
- LVEF normalisation (LVEF ≥55%) in SR, post-catheter ablation or cardioversion (≥3 months post-catheter ablation or cardioversion), no AF (>30 seconds of continuous AF) detected outside blanking period (8 weeks post-catheter ablation), and with no new introduction of any new or increased dose of heart failure guideline-directed medical therapy (GDMT) (renin-angiotensin-aldosterone system inhibitors (RAASi), Sodium Glucose Co-transporter 2 (SLGT2) inhibitors, increased dose of beta-blocker (BB), mineralocorticoid receptor antagonist (MRA))
- AF-pEF (Negative controls):
Show all 14Show fewer
- Age ≥18
- Persistent AF before index catheter ablation or cardioversion
- LVEF ≥55% during rate-controlled (resting HR <100bpm) AF. AIC-genotyping study, v1.7, 27.01.26 Page 13 of 28
- AF/HF non-responders (Positive controls)
- Age ≥18
- Persistent AF before index catheter ablation or cardioversion
- LVEF ≤40% during rate-controlled (resting HR <100bpm) AF before index catheter ablation or cardioversion.
- Persistent LVSD (LVEF ≤40%) in SR, post-catheter ablation or cardioversion (≥3 months post-catheter ablation or cardioversion), no AF (>30 seconds of continuous AF) detected outside blanking period (8 weeks post-catheter ablation) and with no change in heart failure GDMT (RAASi, SGLT2 inhibitors, increased dose of BB, MRA).
Who cannot join
- AIC (Cases).
- No alternative cause for LVSD (ischemic cardiomyopathy/non-ischaemic cardiomyopathy before AF diagnosis, primary valve disease, inherited cardiomyopathy
- Any pregnancy during AF or in the 12 months preceding LVSD onset.
- Alcohol intake >21 units/week
- Any history of cardiotoxic chemotherapy
- AF-pEF (Negative controls)
Show all 15Show fewer
- No known cause for LVSD (ischemic cardiomyopathy/non-ischaemic cardiomyopathy before AF diagnosis, primary valve disease, inherited cardiomyopathy).
- Any pregnancy during AF or in the 12 months preceding LVSD onset.
- Alcohol intake >21 units/week.
- Any history of cardiotoxic chemotherapy.
- AF/HF non-responders (Positive controls)
- No alternative cause for LVSD (ischemic cardiomyopathy/non-ischaemic cardiomyopathy before AF diagnosis, primary valve disease, inherited cardiomyopathy).
- Any pregnancy during AF or in the 12 months preceding LVSD onset.
- Alcohol intake >21 units/week.
- Any history of cardiotoxic chemotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE
Nikhil Ahluwalia, nikhil.ahluwalia@nhs.net
About this study
Official title: Genetic Susceptibility to AF-Induced Cardiomyopathy
To quantify genetic variants in a focused DCM gene panel among AF-induced cardiomyopathy (AIC) and positive/negative controls
Read the detailed description
Atrial Fibrillation (AF) is the most common heart rhythm disorder affecting 1 in 3-5 adults over 45. Although most patients tolerate AF, in some people it can weaken the main pump of the heart (left ventricle), causing heart failure. It is not known why some people develop heart failure during AF and others do not. We propose that individual vulnerability is due to specific genetic abnormalities that do not cause problems until they develop AF. These genetic abnormalities have been identified in patients who develop heart failure with the onset of other stressors, such as alcohol or pregnancy.
Our study will identify 92 patients with AF-triggered heart failure, defined by having heart failure during AF but resolved after the AF was treated using a procedure called catheter ablation. We will measure how common these genetic variations are seen in patients with AF-triggered heart failure and compare them with 184 patients who have AF but don't develop heart failure (negative comparators) and 23 patients who do develop heart failure but do not recover after AF treatment (positive comparators).We shall only test for a limited number of clearly disease-causing genetic variants to ensure cost- effectiveness and minimise the risk of identifying genes of unclear significance.
If we find a genetic association, doctors could: (1) identify patients more likely to develop weakness before the AF becomes persistent, (2) fast-track at-risk patients for catheter ablation treatment, (3) offer family screening where appropriate, and (4) avoid unnecessary testing in low-risk patients. This would directly improve care for people in East London and beyond by personalising AF treatment and preventing avoidable heart failure.
- Conditions
- Cardiomyopathy, Atrial Fibrillation (AF), Genetic
- Keywords
- prospective, case-controlled, genetics
- Medical subject headings
- Cardiomyopathies, 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 |
|---|---|---|
| AF induced Cardiomyopathy (Cases) | Patients with LVSD during rate-controlled, persistent AF who improve their LVEF after sustained SR is achieved using catheter ablation or cardioversion. | |
| AF-preserved EF (Negative controls) | Patients without LVSD during rate-controlled, persistent AF | |
| AF/HF non-responders (Positive controls) | Patients with LVSD during rate-controlled, persistent AF who do not significantly improve their LVEF after sustained SR is achieved using catheter ablation or cardioversion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCM gene prevalence relative to negative control
Group difference between AIC vs AF-pEF in P/LP prevalence from DCM panel
Measured: On day of baseline testing (1 day)
Secondary outcomes (1)
DCM gene prevalence relative to positive control
Group difference between AIC vs AF/HF non-responders in P/LP prevalence.
Measured: On day of baseline testing (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start25 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies 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
- 299 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shohreh Honarbakhsh, MBBS, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574697
- Sponsor's protocol ID
- 368232
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility to AF-Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07574697
- Acronym / sponsor ID
- 368232
- Conditions
- Cardiomyopathy, Atrial Fibrillation (AF), Genetic
- Keywords
- prospective, case-controlled, genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 299 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 May 2026 (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.
To quantify genetic variants in a focused DCM gene panel among AF-induced cardiomyopathy (AIC) and positive/negative controls
Detailed description
Atrial Fibrillation (AF) is the most common heart rhythm disorder affecting 1 in 3-5 adults over 45. Although most patients tolerate AF, in some people it can weaken the main pump of the heart (left ventricle), causing heart failure. It is not known why some people develop heart failure during AF and others do not. We propose that individual vulnerability is due to specific genetic abnormalities that do not cause problems until they develop AF. These genetic abnormalities have been identified in patients who develop heart failure with the onset of other stressors, such as alcohol or pregnancy.
Our study will identify 92 patients with AF-triggered heart failure, defined by having heart failure during AF but resolved after the AF was treated using a procedure called catheter ablation. We will measure how common these genetic variations are seen in patients with AF-triggered heart failure and compare them with 184 patients who have AF but don't develop heart failure (negative comparators) and 23 patients who do develop heart failure but do not recover after AF treatment (positive comparators).We shall only test for a limited number of clearly disease-causing genetic variants to ensure cost- effectiveness and minimise the risk of identifying genes of unclear significance.
If we find a genetic association, doctors could: (1) identify patients more likely to develop weakness before the AF becomes persistent, (2) fast-track at-risk patients for catheter ablation treatment, (3) offer family screening where appropriate, and (4) avoid unnecessary testing in low-risk patients. This would directly improve care for people in East London and beyond by personalising AF treatment and preventing avoidable heart failure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AF induced Cardiomyopathy (Cases) | – | –Patients with LVSD during rate-controlled, persistent AF who improve their LVEF after sustained SR is achieved using catheter ablation or cardioversion. |
| AF-preserved EF (Negative controls) | – | –Patients without LVSD during rate-controlled, persistent AF |
| AF/HF non-responders (Positive controls) | – | –Patients with LVSD during rate-controlled, persistent AF who do not significantly improve their LVEF after sustained SR is achieved using catheter ablation or cardioversion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with a diagnosis of persistent AF who have undergone AF CA. Their LVEF at baseline and after CA in Sinus rhythm will determine eligibility. Barts Heart Centre, based at St Bartholomew's Hospital is a tertiary referral centre for cardiac electrophysiology with established expertise in AF CA. This will be the single study site. The team performed approximately 1300 index procedure AF CAs in 2018. Referral for AF CA to Barts Heart Centre is through a 'hub and spoke' arrhythmia service delivery model with its surrounding hospitals. Patients will be referred to the CRF for screening from the Electrophysiology out-patients clinic alongside the referral for AF CA. Vulnerable groups shall be excluded from this study.
Key inclusion criteria (14 listed)
- Age ≥18
- Persistent AF before index catheter ablation or cardioversion
- LVEF ≤40% during rate-controlled (resting HR <100bpm, mean HR on 24-hour Holter <100bpm) AF prior to index catheter ablation or cardioversion
- LVEF normalisation (LVEF ≥55%) in SR, post-catheter ablation or cardioversion (≥3 months post-catheter ablation or cardioversion), no AF (>30 seconds of continuous AF) detected outside blanking period (8 weeks post-catheter ablation), and with no new introduction of any new or increased dose of heart failure guideline-directed medical therapy (GDMT) (renin-angiotensin-aldosterone system inhibitors (RAASi), Sodium Glucose Co-transporter 2 (SLGT2) inhibitors, increased dose of beta-blocker (BB), mineralocorticoid receptor antagonist (MRA))
- Age ≥18
Key exclusion criteria (15 listed)
- AIC (Cases).
- No alternative cause for LVSD (ischemic cardiomyopathy/non-ischaemic cardiomyopathy before AF diagnosis, primary valve disease, inherited cardiomyopathy
- Any pregnancy during AF or in the 12 months preceding LVSD onset.
- Alcohol intake >21 units/week
- Any history of cardiotoxic chemotherapy
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
DCM gene prevalence relative to negative control
Time frame: On day of baseline testing (1 day)
Group difference between AIC vs AF-pEF in P/LP prevalence from DCM panel
1 secondary outcome
DCM gene prevalence relative to positive control
Time frame: On day of baseline testing (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Shohreh Honarbakhsh, MBBS, PhD principal investigator
Queen Mary University of London
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 Cardiomyopathy and Atrial Fibrillation (AF), 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 14 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikhil Ahluwalia, MBBS, PhD (+44(0) 20 3465 5398, nikhil.ahluwalia@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCM gene prevalence relative to negative control (time frame: On day of baseline testing (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.