RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases
NCT07491237
Arrhythmia, Arrhythmias, Cardiac
View Trial DetailsNCT Number: NCT06896266
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. 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?
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ciudad Real General University Hospital, Ciudad Real, Castille-La Mancha, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion, an average of 1 year
Presence of pathogenic/likely pathogenic genetic variant in genetic test
Time frame: Through study completion, an average of 1 year
Incidence of new hospitalización or urgent visit due to heart failure requiring intravenous diuretics
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Incidence of unplanned electrical cardioversion or catheter ablation of an atrial tachyarrhythmia (Atrial fibrillation, atrial flutter or atrial tachycardia)
Time frame: Through study completion, an average of 1 year
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
Time frame: Through study completion, an average of 1 year
Incidence of unplanned hospital admission due to a cardiovascular aethiology, including acute coronary syndrome, rhythm disorder, heart failure, valvular heart disease, cardiogenic syncope, ischaemic stroke or transient ischaemic attack, acute aortic syndrome, pulmonary or systemic embolism or unexplained sudden cardiac death.
Time frame: Through study completion, an average of 1 year
Death of any cause. Cardiovascular death will be also asesed
Contact information is provided by the study sponsor or research team.
Daniel Rodríguez-Muñoz, MD, PhD
CONTACT
Martín Negreira-Caamaño, MD, PhD
CONTACT
Hospital Universitario 12 de Octubre
Other
Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy
Acronym: UNCHAINED-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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