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AIC Genotyping Study

5 maj 2026 uppdaterad av: Barts & The London NHS Trust

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

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

299

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

INCLUSION:

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).

EXCLUSION:

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DCM gene prevalence relative to negative control
Tidsram: On day of baseline testing (1 day)
Group difference between AIC vs AF-pEF in P/LP prevalence from DCM panel
On day of baseline testing (1 day)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DCM gene prevalence relative to positive control
Tidsram: On day of baseline testing (1 day)
Group difference between AIC vs AF/HF non-responders in P/LP prevalence.
On day of baseline testing (1 day)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Genotype-recovery time association
Tidsram: 12 months post-ablation time-point (independent of study enrolment date)

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Barts & The London NHS Trust

Utredare

  • Huvudutredare: Shohreh Honarbakhsh, MBBS, PhD, Queen Mary University of London

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 mars 2026

Primärt slutförande (Beräknad)

31 mars 2027

Avslutad studie (Beräknad)

31 maj 2027

Studieregistreringsdatum

Först inskickad

20 april 2026

Först inskickad som uppfyllde QC-kriterierna

5 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 368232

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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