Characterization of Arrhythmia-induced Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662293
• Other study ID #: 2021-00873; kt22Badertscher2
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Patrick Badertscher, MD
• Phone: +41 61 556 58 23
• Email: patrick.badertscher[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Cardiomyopathy

Intervention

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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Cardiology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one time data extraction and analysis at baseline
Primary	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)	at 1 year Follow- up
Primary	Change in Major adverse cardiovascular events (MACE) assessment questionnaire	MACE is a composite endpoint of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.	at 6 months, 1 year, 2 year and 5 year Follow- up
Secondary	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	up to 5 years
Secondary	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	up to 5 years
Secondary	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	up to 5 years
Secondary	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	one time data extraction and analysis
Secondary	Number of patients with tachymyopathies (prospective part)	supraventricular tachycardias such as atrial fibrillation, atrial flutter or atrial tachycardia vs premature-ventricular complex induced arrhythmia-induced cardiomyopathy versus right-ventricle pacing induced arrhythmia-induced cardiomyopathy	up to 5 years
Secondary	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)	The EQ-5D-5L consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.; The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	at 6 months, 1 year, 2 year and 5 year Follow- up