NCT05662293

Characterization of Arrhythmia-induced Cardiomyopathy

Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiomyopathy
• Arrhythmia-induced Cardiomyopathy (AiCM)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-10
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-12-22
• Last updated: 2025-03-04

Locations

1 site across 1 country: Switzerland