Characterization of Arrhythmia-induced Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part)
Other interventionData collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone
Data collection: Quality of Life (QoL) Questionnaire (prospective part)
Other interventionData collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.
Data collection (retrospective study)
Other interventionAnonymized 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.
Data collection (prospective study database)
Other interventionData collection on alcohol consumption, family history, rhythm disorder, hospitalizations, cardiac assessments, adverse events at baseline, 6 months, 1 year, 2 years and 5 years.
Treatment groups
2,700 Participants
are divided into 1 treatment groupGroup A: Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)4 interventions
Trial outcomes
Primary outcomes
1
Incidence of AiCM (retrospective part of the study)
Categorization (based on a diagnostic algorithm) into 4 categories: "Likely AiCM", "possibly AiCM", "unlikely AiCM" and "Diagnostic work-up and longitudinal assessment insufficient to establish diagnosis" done by study team. AiCM will be defined as the presence of a reduced (\<50%) ejection fraction in a transthoracic echocardiography (TTE) with a concomitant diagnosis of an arrhythmia present in the electronic patient's chart 6 months before or after the date of the diagnostic study.
Time frame
one time data extraction and analysis at baseline2
Incidence of AiCM (Prospective part of the study)
Categorization using a "goldstandard diagnosis (GSD)": diagnosis by 2 independent cardiologists based on all data from the initial hospital stay and follow-up. The most likely diagnosis will be chosen among a list of comprehensive, pre-selected choices (Standard operating procedures (SOP) provided to the adjudicators to ensure homogenous knowledge and adjudication process. The booklet will contain information from the guidelines and position papers)
Time frame
at 1 year Follow- up3
Change in Major adverse cardiovascular events (MACE) assessment questionnaire
MACE is a composite endpoint of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
Time frame
at 6 months, 1 year, 2 year and 5 year Follow- upSecondary outcomes
1
Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part)
Data generated by patient's chart review and automated IT export
Time frame
up to 5 years2
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)
Data generated by patient's chart review and automated IT export
Time frame
up to 5 years3
Percentage of patients in whom the goldstandard diagnosis procedures came to a different diagnosis than the one done by the clinician. (prospective part)
Data generated by patient's chart review and automated IT export
Time frame
up to 5 years4
Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part)
Data generated by patient's chart review and automated IT export
Time frame
one time data extraction and analysisSponsors and contacts
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Source ClinicalTrials.gov