Characterization of Arrhythmia-induced Cardiomyopathy

Official title

Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study

Overview

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.

Interventions

• Other Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)
  Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone
• Other Data collection: Quality of Life (QoL) Questionnaire (prospective part)
  Data collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.
• Other Data collection (retrospective study)
  Anonymized search and review of patients electronic health records of the University Hospital of Basel for patients with a reduced LVEF and a concomitant (±1year or after any observation of a reduced LVEF in imaging) diagnosis of arrhythmia known to be causing AiCM.
• Other Data collection (prospective study database)
  Data collection on alcohol consumption, family history, rhythm disorder, hospitalizations, cardiac assessments, adverse events at baseline, 6 months, 1 year, 2 years and 5 years.

Primary outcome measures

• Incidence of AiCM (retrospective part of the study) [Time frame: one time data extraction and analysis at baseline]
• Incidence of AiCM (Prospective part of the study) [Time frame: at 1 year Follow- up]
• Change in Major adverse cardiovascular events (MACE) assessment questionnaire [Time frame: at 6 months, 1 year, 2 year and 5 year Follow- up]

Secondary outcome measures (6)

• Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part) [Time frame: up to 5 years]
• 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) [Time frame: up to 5 years]
• Percentage of patients in whom the goldstandard diagnosis procedures came to a different diagnosis than the one done by the clinician. (prospective part) [Time frame: up to 5 years]
• Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part) [Time frame: one time data extraction and analysis]
• Number of patients with tachymyopathies (prospective part) [Time frame: up to 5 years]
• 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) [Time frame: at 6 months, 1 year, 2 year and 5 year Follow- up]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• University Hospital Basel, Department of Cardiology — Basel

Identifiers

NCT: NCT05662293 · 2021-00873; kt22Badertscher2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗