AIC Genotyping Study

May 5, 2026 updated by: 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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On day of baseline testing (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCM gene prevalence relative to positive control
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype-recovery time association
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 368232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiomyopathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe