CardiomyopathyNCT05662293
Characterization of Arrhythmia-induced Cardiomyopathy
An observational study of Cardiomyopathy and Arrhythmia-induced Cardiomyopathy (AiCM), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Arrhythmia-induced Cardiomyopathy (AiCM)
- What is being tested?
- Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part), Data collection: Quality of Life (QoL) Questionnaire (prospective part) and Data collection (retrospective study)
- How many people
- 2,700 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jun 2021to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Age < 18 years old
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Department of Cardiology
Basel, 4031
Patrick Badertscher, MD, +41 61 556 58 23, patrick.badertscher@usb.ch
Teodor Serban, Dr. med., +41 77 911 39 08, teodor.serban@usb.ch
About this study
Official title: Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study
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.
Read the 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.
- Being tested
- Data collection: Major adverse cardiovascular event (MACE) assessment questionnaire (prospective part), Data collection: Quality of Life (QoL) Questionnaire (prospective part), Data collection (retrospective study), Data collection (prospective study database)
- Keywords
- atrial fibrillation (AF), supraventricular tachycardia (SVT), ventricular tachycardia, atrial flutter, Major Adverse Cardiovascular Event (MACE), cardiac arrhythmia
- Medical subject headings
- Cardiomyopathies, Atrial Fibrillation, Tachycardia, Supraventricular, Tachycardia, Ventricular, Atrial Flutter, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) | retrospective cohort and case-control study followed by a prospective observational cohort study. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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)
Data generated by patient's chart review and automated IT export
Measured: 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)
Data generated by patient's chart review and automated IT export
Measured: 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)
Data generated by patient's chart review and automated IT export
Measured: up to 5 years
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
Measured: one time data extraction and analysis
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
Measured: up to 5 years
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.
Measured: at 6 months, 1 year, 2 year and 5 year Follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start10 Jun 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Badertscher, MD, Principal investigator, University Hospital Basel, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662293
- Sponsor's protocol ID
- 2021-00873; kt22Badertscher2
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmia-induced Cardiomyopathy - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05662293
- Acronym / sponsor ID
- 2021-00873; kt22Badertscher2
- Keywords
- atrial fibrillation (AF), supraventricular tachycardia (SVT), ventricular tachycardia, atrial flutter, Major Adverse Cardiovascular Event (MACE), cardiac arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) | – | 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)retrospective cohort and case-control study followed by a prospective observational cohort study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) |
| 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 | Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) |
| 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 | Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) |
| 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. | Other | Patients with arrhythmia-induced cardiomyopathy (retrospective/prospective) |
Primary outcome
Incidence of AiCM (retrospective part of the study)
Time frame: one time data extraction and analysis at baseline
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.
Incidence of AiCM (Prospective part of the study)
Time frame: at 1 year Follow- up
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)
Change in Major adverse cardiovascular events (MACE) assessment questionnaire
Time frame: at 6 months, 1 year, 2 year and 5 year Follow- up
MACE is a composite endpoint of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
6 secondary outcomes
Percentage of patients in whom a diagnosis of AiCM could be diagnosed or excluded with certainty per goldstandard diagnosis. (prospective part)
Time frame: 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)
Time frame: 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)
Time frame: up to 5 years
Frequency of hybrid (both antiarrhythmics and ablation) or a sequential (first anti-arrhythmic and then ablation) therapeutic options (prospective part)
Time frame: one time data extraction and analysis
Number of patients with tachymyopathies (prospective part)
Time frame: up to 5 years
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)
Time frame: at 6 months, 1 year, 2 year and 5 year Follow- up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Badertscher, MD principal investigator
University Hospital Basel, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Arrhythmia-induced Cardiomyopathy (AiCM), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Badertscher, MD (+41 61 556 58 23, patrick.badertscher@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AiCM (retrospective part of the study) (time frame: one time data extraction and analysis at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.