Characterization of Arrhythmia-induced Cardiomyopathy

NCT05662293 | Recruiting

• 1 other identifier: 2021-00873; kt22Badertscher2
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiomyopathy; Arrhythmia-induced Cardiomyopathy (AiCM)

Keywords

atrial fibrillation (AF); supraventricular tachycardia (SVT); ventricular tachycardia; atrial flutter; Major Adverse Cardiovascular Event (MACE); cardiac arrhythmia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part)

  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)

  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)

  up to 5 years

• Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part)

  one time data extraction and analysis

• Number of patients with tachymyopathies (prospective part)

  up to 5 years

Study Arms (1)

Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)

retrospective cohort and case-control study followed by a prospective observational cohort study.

Other: Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part); Other: Data collection: Quality of Life (QoL) Questionnaire (prospective part); Other: Data collection (retrospective study); Other: Data collection (prospective study database)

Interventions

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

Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part). The assessment will be done via mail, letter or phone

Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)

Data collection: Quality of Life (QoL) Questionnaire (prospective part) OTHER

Data collection: Quality of Life (QoL) Questionnaire (prospective part). The questionnaire "EQ-5D-5L questionnaire" will be used to assess quality of life.

Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)

Data collection (retrospective study) OTHER

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.

Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)

Data collection (prospective study database) OTHER

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.

Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Patient's active refusal of the general consent of the University Hospital Basel
• Age \<18 years old
• Life expectancy \<1 year (palliative, terminal cancer)
• Retrospective part
• 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
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Cardiology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies; Atrial Fibrillation; Tachycardia, Supraventricular; Tachycardia, Ventricular; Atrial Flutter; Arrhythmias, Cardiac

Interventions

omega-Chloroacetophenone; Quality of Life; Surveys and Questionnaires; Data Collection; Retrospective Studies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Cohort Studies

Study Officials

• Patrick Badertscher, MD

  University Hospital Basel, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Badertscher, MD

CONTACT

+41 61 556 58 23; patrick.badertscher@usb.ch

Jeanne du Fay de Lavallaz, MD-PhD

CONTACT

+41 61 328 76 44; jeanne.dufay@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: June 10, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

CH (1)