AIC Genotyping Study

NCT07574697 | Recruiting DMC

• 1 other identifier: 368232
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

To quantify genetic variants in a focused DCM gene panel among AF-induced cardiomyopathy (AIC) and positive/negative controls

Conditions

Cardiomyopathy; Atrial Fibrillation (AF); Genetic

Keywords

prospective; case-controlled; genetics

Outcome Measures

Primary Outcomes (1)

• DCM gene prevalence relative to negative control

  Group difference between AIC vs AF-pEF in P/LP prevalence from DCM panel

  On day of baseline testing (1 day)

Secondary Outcomes (1)

• DCM gene prevalence relative to positive control

  On day of baseline testing (1 day)

Other Outcomes (1)

• Genotype-recovery time association

  12 months post-ablation time-point (independent of study enrolment date)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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):
• 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).

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

St Bartholomew's Hospital, Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Cardiomyopathies; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shohreh Honarbakhsh, MBBS, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikhil Ahluwalia, MBBS, PhD

CONTACT

+44(0) 20 3465 5398; nikhil.ahluwalia@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 8, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)