Clinical trial NCT05662293: Characterization of Arrhythmia-induced Cardiomyopathy
Official title: Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathy
Arrhythmia-induced Cardiomyopathy (AiCM)
Keywords: atrial fibrillation (AF)
supraventricular tachycardia (SVT)
ventricular tachycardia
atrial flutter
Major Adverse Cardiovascular Event (MACE)
cardiac arrhythmia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective part (1500 patients):

Patients which have been or currently are in treatment for an AiCM at the University Hospital Basel or who received a new diagnosis/suspicion of such a disease will be included. Patients who have just recovered from an AiCM they presented in the last 10 years will also be enrolled and prospectively followed.

Retrospective part (1200 patients):

Patients with a reduced LVEF (≤50%) or with a reduction of the EF of 15% between two echocardiographies and a concomitant diagnosis of arrhythmia (within one year prior or after the diagnosis of reduced EF) at the University Hospital Basel will be retrospectively identified by conducting a search in the electronic records for keywords of arrhythmia diagnosis and/or reduced EF in several imaging types.

Brief summary: The goal of the this observational study is to gather clinically available data on patients presenting with a suspicion for arrhythmia-induced cardiomyopathy (AiCM) at the University Hospital Basel.

Detailed description: Current studies indicate that AiCM is an under-recognized and an underestimated clinical entity and its prevalence is poorly documented. This project consists of a retrospective longitudinal cohort and case-control study followed by a prospective observational cohort study.

The retrospective pilot study (1200 patients) is to define the incidence of AiCM in patients who presented to the University Hospital of Basel with a reduced left ventricular ejection fraction before or after the diagnosis of an arrhythmia suggestive to lead to an AiCM.

The prospective study part (1500 patients) is to evaluate the predictors of adverse events and re-hospitalizations in patients with a suspicion of AiCM. The diagnosis of AiCM will be established using a "goldstandard diagnosis": 2 independent cardiologists will adjudicate the diagnosis based on all data from the initial hospital stay and follow-up including ECG, laboratory measurements, vital signs, echocardiography, coronary angiography, stress testing and other cardiovascular diagnostic steps. The most likely diagnosis will be chosen among a list of comprehensive, pre-selected choices. In cases of disagreement of the two reviewers, diagnosis will be discussed with a third senior physician and decision made.

In order to optimize the care of patients with AiCM, the researchers intend to determine the prevalence of AICM, evaluate diagnostic criteria that allow an early diagnosis of AICM, and evaluate the current therapeutic management and prognosis of patients with AICM.

Eligibility criteria: Prospective part

Inclusion Criteria:

* Diagnostic or suspicion of AiCM as presence of specified keyword in patient's file or as screened by colleagues of the internal medicine or cardiology clinics
* Signed study consent

Exclusion Criteria:

* Patient's active refusal of the general consent of the University Hospital Basel
* Age \<18 years old
* Temporary exclusion criteria: Acute health condition such as myocardial infarction, patients presenting with a major trauma, a sepsis, patients shortly after cardiac surgery, and patients in shock (\>100 bpm, \<90 systolic BP, evidence of organ dysfunction).
* Life expectancy \<1 year (palliative, terminal cancer)

Retrospective part

Inclusion Criteria:

* Patients with a reduced left-ventricular ejection fraction (LVEF ≤50%) or a reduction of 15% in the ejection fraction (EF) between two echocardiographies and a concomitant diagnosis of any arrhythmia likely to lead to AiCM within one year before or after diagnosis of the reduced LVEF from 2010-2021

Exclusion Criteria:

* Age \< 18 years old
* Patient's active refusal of the general consent of the University Hospital Basel
* Acute event clearly leading to an acutely reduced LVEF (massive type I myocardial infarction, cardiogenic shock from a coronary or myocardial etiology, septic shock leading to toxic myopathy, hypovolemic shock with reduced EF, cardiac arrest and/or need for resuscitation).
* Patients with life expectancy \<1 year (palliative, terminal cancer)

Primary outcomes:
measure: Incidence of AiCM (retrospective part of the study)
timeFrame: one time data extraction and analysis at baseline
measure: Incidence of AiCM (Prospective part of the study)
timeFrame: at 1 year Follow- up
measure: Change in Major adverse cardiovascular events (MACE) assessment questionnaire
timeFrame: at 6 months, 1 year, 2 year and 5 year Follow- up
Secondary outcomes:
measure: Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part)
timeFrame: up to 5 years
measure: Percentage of patients in whom a diagnosis of AiCM could not surely be established and/or where an overlap with another cause of cardiomyopathy was present per goldstandard diagnosis. (prospective part)
timeFrame: up to 5 years
measure: Percentage of patients in whom the goldstandard diagnosis procedures came to a different diagnosis than the one done by the clinician. (prospective part)
timeFrame: up to 5 years
measure: Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part)
timeFrame: one time data extraction and analysis
measure: Number of patients with tachymyopathies (prospective part)
timeFrame: up to 5 years
measure: Change in European Quality of Life 5 Dimensions (EQ-5D-5L) quality of life (QoL) questionnaire in patients with and without a arrhythmia-induced cardiomyopathy (prospective part)
timeFrame: at 6 months, 1 year, 2 year and 5 year Follow- up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Cardiology
Study officials:
affiliation: University Hospital Basel, Department of Cardiology
name: Patrick Badertscher, MD
role: PRINCIPAL_INVESTIGATOR
References: