Characterization of Arrhythmia-induced Cardiomyopathy

Phase

N/A

Condition

Circulation Disorders

Cardiomyopathy

Treatment

Data collection (prospective study database)

Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)

Data collection (retrospective study)

Clinical Study ID

NCT05662293

2021-00873; kt22Badertscher2

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Prospective part

Inclusion Criteria:

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

Exclusion

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 cardiacsurgery, and patients in shock (>100 bpm, <90 systolic BP, evidence of organdysfunction).
Life expectancy <1 year (palliative, terminal cancer)

Retrospective part

Inclusion Criteria:

Patients with a reduced left-ventricular ejection fraction (LVEF ≤50%) or areduction of 15% in the ejection fraction (EF) between two echocardiographies and aconcomitant diagnosis of any arrhythmia likely to lead to AiCM within one yearbefore 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 myocardialinfarction, cardiogenic shock from a coronary or myocardial etiology, septic shockleading to toxic myopathy, hypovolemic shock with reduced EF, cardiac arrest and/orneed for resuscitation).
Patients with life expectancy <1 year (palliative, terminal cancer)

Study Design

Data collection (prospective study database)

June 10, 2021

January 31, 2027

Study 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.

Connect with a study center

University Hospital Basel, Department of Cardiology
Basel, 4031
Switzerland
Active - Recruiting

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