AIC Genotyping Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
About this trial
To quantify genetic variants in a focused DCM gene panel among AF-induced cardiomyopathy (AIC) and positive/negative controls
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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))
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
299 Participants
are grouped into 3 trial groupsGroup A: AF induced Cardiomyopathy (Cases)
Group B: AF-preserved EF (Negative controls)
Group C: AF/HF non-responders (Positive controls)
Trial outcomes
Primary outcomes
1
DCM gene prevalence relative to negative control
Group difference between AIC vs AF-pEF in P/LP prevalence from DCM panel
Time frame
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.
Time frame
On day of baseline testing (1 day)Other outcomes
1
Genotype-recovery time association
Time from durable SR to LVEF normalisation: by genotype (TTNtv; any P/LP): HR from Cox models. Change in LVEF (post-SR minus pre-SR) by genotype: β from linear regression. Rapid recovery proportion (normalisation ≤90 days) by genotype
Time frame
12 months post-ablation time-point (independent of study enrolment date)Sponsors and contacts
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Source ClinicalTrials.gov