ArrhythmiaUNCHAINED-INCT06896266
Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
An observational study of Arrhythmia and Cardiomyopathy, run by Hospital Universitario 12 de Octubre at 4 sites in Spain.
Trial summary
The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are: I. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Cardiomyopathy, Arrhythmia-induced Cardiomyopathy (AiCM)
- How many people
- 109 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Dec 2024to Dec 2027
- How long will I take part?
- 1 Year
- 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: Patient with clinical suspected arrhythmia-induced cardiomyopathy
Who may be able to join
- Presence of atrial fibrillation or atrial flutter not self-limited.
- Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) <50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF <50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.
- Signature of informed consent.
- Ability to understand and accept participation in the study.
Who cannot join
- Refusal of informed consent.
- Legal or juridical incapacity.
- Age <18 years.
- Life expectancy less than 1 year.
- Impossibility of a follow-up of at least 6 months.
- Presence of a ventricular rate >140 beats per minute, limiting the validity of imaging measurements.
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- Presence of known factors causing systolic ventricular dysfunction:
- Prior cardiomyopathy diagnosis.
- Severe mitral or aortic valve disease.
- Non-revascularizable ischemic heart disease.
- Context of peri-resuscitation cardiopulmonary care.
- Abusive alcohol consumption, defined as >80 grams of ethanol or >7 standard alcoholic beverages per day.
- Active treatment with chemotherapeutic agents or radiation therapy to the thorax.
- Known infection with Trypanosoma cruzi, Borrellia burgdorferi or other infectious agent causing cardiomyopathy.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 3 recruiting
- Not yet recruiting
Albacete University Hospital Complex
Albacete
Sofía Calero-Nuñez, MD, PhD, 967597100, sofia.caleron@gmail.com
- Recruiting
Ciudad Real General University Hospital
Ciudad Real, Castille-La Mancha, 15004
Jesús Piqueras-Flores, MD, PhD, 926278000, jpiqueras@sescam.jccm.es
- Recruiting
12 de Octubre University Hospital
Madrid, Madrid, 28004
Martín Negreira Caamaño, MD, PhD, +34913908000, martin.negcam@gmail.com
- Active, not recruiting
Ramón y Cajal University Hospital
Madrid
About this study
Official title: Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy
The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are:
- Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?
Read the detailed description
This is a multicentric prospective observational study including patients with suspected arrhythmia-induced cardiomyopathy (AiC) and undergoing rhythm control strategy. AiC suspicion is defined by the presence of left ventricular ejection fraction <50% with no other more plausible explanation than a new-onset arrhythmia.
Patients who met the inclusion/exclusion criteria will be followed during 1 year after the rhythm control procedure (electric cardioversion or catheter ablation) to asess rhythm control status, imaging remodeling and clinical events. A genetic test will be performed during the study time to asess the existace of genetic variants in cardiomyopathy-related genes. Follow-up visits will be scheduled at 2, 6 and 12 months after inclusion and electrocardiogram and echocardiography will be performed.
AiC will be confirmed in case of left ventricular ejection fraction recovery >10% or absolute value >54% during the follow up imaging evaluations.
Primary analysis will asess the prevalence of pathogenic /likely patogenic variants in patients fullfilling AiC criteria and compared with those who not (without AiC). Secondary analysis will be focused on the incidence of cardiovascular events (heart failure-related and rhythm control-related) during the follow up and its relationship with the genetic background and the AiC status.
Imaging test during follow up will be performed and changes in ventricular and atrial parameters will be used to asess cardiac remodeling.
Further rhythm control asessment will be performed following routinary clinical practice in each participant center.
- Keywords
- atrial fibrillation, atrial flutter, heart failure, arrhythmia-induced cardiomyopathy, cardiomyopathy, genetics
- Medical subject headings
- Arrhythmias, Cardiac, Cardiomyopathies, Atrial Fibrillation, Atrial Flutter, Heart Failure
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 |
|---|---|---|
| A | Patients with arrhytmia-induced cardiomyopathy criteria | |
| B | Patients without arrhytmia-induced cardiomyopathy criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pathogenic or likely pathogenic variants in genetic test
Presence of pathogenic/likely pathogenic genetic variant in genetic test
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Heart Failure Admission
Incidence of new hospitalización or urgent visit due to heart failure requiring intravenous diuretics
Measured: Through study completion, an average of 1 year
Arrhythmia recurrence
Incidence of any atrial tachyarrhytmia (Atrial fibrillation, atrial flutter or atrial tachycardia) conditioning an atrial rate >150 beats per minute and with a duration of >5 minutes.
Measured: Through study completion, an average of 1 year
New unplanned rhythm control procedure
Incidence of unplanned electrical cardioversion or catheter ablation of an atrial tachyarrhythmia (Atrial fibrillation, atrial flutter or atrial tachycardia)
Measured: Through study completion, an average of 1 year
Atrial reverse remodelling
Incidence of atrial reverse remodelling (ARR). ARR will be considered with a decrease in >1 degree of atrial dilatation (0=non dilated; 1= mild; 2=moderate; 3=severe) or a decrease >15% in the left atrial indexed volume
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martín Negreira-Caamaño, MD, PhD, Hospital Universitario 12 de Octubre
- Investigators
- Martín Negreira-Caamaño, MD, PhD, Study director, Cardiology department, 12 de Octubre University HospitalRafael Salguero-Bodes, MD, Study director, Cardiology Department, 12 de Octubre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896266
- Sponsor's protocol ID
- 24/391
- Acronym
- UNCHAINED-I
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serban T, Badertscher P, du Fay de Lavallaz J, Providencia R, Migliore F, Mugnai G, Penela D, Perrotta L, Kuhne M, Sticherling C, Chun KJ. Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey. Europace. 2024 May 2;26(5):euae112. doi: 10.1093/europace/euae112.
PubMed 38693772Shoureshi P, Tan AY, Koneru J, Ellenbogen KA, Kaszala K, Huizar JF. Arrhythmia-Induced Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Jun 4;83(22):2214-2232. doi: 10.1016/j.jacc.2024.03.416.
PubMed 38811098
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06896266
- Acronym / sponsor ID
- UNCHAINED-I / 24/391
- Keywords
- atrial fibrillation, atrial flutter, heart failure, arrhythmia-induced cardiomyopathy, cardiomyopathy, genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Mar 2025 (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.
The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are:
- Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?
Detailed description
This is a multicentric prospective observational study including patients with suspected arrhythmia-induced cardiomyopathy (AiC) and undergoing rhythm control strategy. AiC suspicion is defined by the presence of left ventricular ejection fraction <50% with no other more plausible explanation than a new-onset arrhythmia.
Patients who met the inclusion/exclusion criteria will be followed during 1 year after the rhythm control procedure (electric cardioversion or catheter ablation) to asess rhythm control status, imaging remodeling and clinical events. A genetic test will be performed during the study time to asess the existace of genetic variants in cardiomyopathy-related genes. Follow-up visits will be scheduled at 2, 6 and 12 months after inclusion and electrocardiogram and echocardiography will be performed.
AiC will be confirmed in case of left ventricular ejection fraction recovery >10% or absolute value >54% during the follow up imaging evaluations.
Primary analysis will asess the prevalence of pathogenic /likely patogenic variants in patients fullfilling AiC criteria and compared with those who not (without AiC). Secondary analysis will be focused on the incidence of cardiovascular events (heart failure-related and rhythm control-related) during the follow up and its relationship with the genetic background and the AiC status.
Imaging test during follow up will be performed and changes in ventricular and atrial parameters will be used to asess cardiac remodeling.
Further rhythm control asessment will be performed following routinary clinical practice in each participant center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with arrhytmia-induced cardiomyopathy criteria |
| B | – | –Patients without arrhytmia-induced cardiomyopathy criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with clinical suspected arrhythmia-induced cardiomyopathy
Key inclusion criteria (4 listed)
- Presence of atrial fibrillation or atrial flutter not self-limited.
- Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) <50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF <50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.
- Signature of informed consent.
- Ability to understand and accept participation in the study.
Key exclusion criteria (14 listed)
- Refusal of informed consent.
- Legal or juridical incapacity.
- Age <18 years.
- Life expectancy less than 1 year.
- Impossibility of a follow-up of at least 6 months.
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
Prevalence of pathogenic or likely pathogenic variants in genetic test
Time frame: Through study completion, an average of 1 year
Presence of pathogenic/likely pathogenic genetic variant in genetic test
4 secondary outcomes
Heart Failure Admission
Time frame: Through study completion, an average of 1 year
Arrhythmia recurrence
Time frame: Through study completion, an average of 1 year
New unplanned rhythm control procedure
Time frame: Through study completion, an average of 1 year
Atrial reverse remodelling
Time frame: Through study completion, an average of 1 year
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 15 Sep 2026.
- Results publication: PubMed 38693772Serban T, Badertscher P, du Fay de Lavallaz J, Providencia R, Migliore F, Mugnai G, Penela D, Perrotta L, Kuhne M, Sticherling C, Chun KJ. Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey. Europace. 2024 May 2;26(5):euae112. doi: 10.1093/europace/euae112.
- Results publication: PubMed 38811098Shoureshi P, Tan AY, Koneru J, Ellenbogen KA, Kaszala K, Huizar JF. Arrhythmia-Induced Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Jun 4;83(22):2214-2232. doi: 10.1016/j.jacc.2024.03.416.
- Individual participant dataSharing planned: Undecided
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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.
Martín Negreira-Caamaño, MD, PhD study director
Cardiology department, 12 de Octubre University Hospital
Rafael Salguero-Bodes, MD study director
Cardiology Department, 12 de Octubre University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Cardiomyopathy, run by Hospital Universitario 12 de Octubre at 4 sites in Spain.
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 4 inclusion and 14 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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 Martín Negreira-Caamaño, MD, PhD (+34913908000, martin.negcam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pathogenic or likely pathogenic variants in genetic test (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06896266, which also lists 2 linked publications.
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 15 Sep 2026.