Takotsubo CardiomyopathyLONG-TAKENCT05084157
Long-term Echocardiographic Findings in Takotsubo Syndrome
An observational study of Takotsubo Cardiomyopathy, run by University of Roma La Sapienza.
Trial summary
Takotsubo syndrome (TTS) is characterized by severe left ventricular (LV) dysfunction that gradually recovers, thus leading to the commonly accepted belief that it is a transient and self-limiting condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- Echocardiography
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients diagnosed as having Takotsubo Syndrome on the basis of Mayo Criteria
Who may be able to join
- Diagnosis of TTS according to current International consensus criteria
- Written informed consent
- Age 18 years and over
Who cannot join
- Secondary form of TTS (e.g. as it can occur after sepsis, neurological disorders, pheochromocytoma)
- Durg-induced form of TTS (e.g. after administration of drugs such as dopamine, dobutamine, epinephrine, or norepinephrine)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicentre, International, Registry of LONG-term Findings at Cardiac Imaging in TAKotsubo SyndromE (The LONG-TAKE Registry)
Takotsubo syndrome (TTS) is characterized by severe left ventricular (LV) dysfunction that gradually recovers, thus leading to the commonly accepted belief that it is a transient and self-limiting condition.
Histologically, TTS can be accompanied by severe morphological alterations potentially resulting from catecholamine excess followed by microcirculatory dysfunction and direct cardiotoxicity. The affected myocardium, however, has a high potential of structural reconstitution which correlates with the rapid functional recovery. The lack of persistent morphological changes in TTS has been confirmed by original CMR studies which pointed out that the acute phase of the disease is characterized only by remarkable myocardial edema with no evidence of significant late gadolinium enhancement. Indeed, the absence of LGE in TTS patients has become a common diagnostic criterion in most CMR centers. Although some studies have challenged this notion by reporting delayed hyper-enhancement in TTS patients, the intensity and extent of LGE in the acute phase of TTS are less than usually reported in studies of myocardial infarction.
The long-term clinical and functional consequences of an acute episode of TTS are still unclear. A recent spectroscopic investigation has shown that long-term (>1 year) abnormalities in cardiac energetic persist after an acute episode of TTS. Also, a few patients with residual wall motion abnormality in whom LGE fails to resolve (suggesting the acute event resulted in frank infarction) have been reported. However, how often persistent morphologic abnormalities are present after the index episode remains undefined. The possibility exists that fibrosis was undetected at follow-up CMR studies using conventional LGE threshold methods due to the fact that myocardial injury is subtler and there are no confidently recognizable reference regions of normal myocardium. Newer echocardiographic tools (i.e. tissue Doppler) have now the potential to detect persistence of post-TTS LV function abnormalities.
Read the detailed description
Objective of the study The aim of this study is to assess the frequency of long-term (>12 months) morphologic abnormalities at cardiac imaging after an index episode of TTS, and their possible correlation with presenting features and long-term outcome
Study Population The registry will enrol consecutive patients with TS who have undergone echocardiography either at entry and during follow-up (>12 months).
Registry Design This is a non-interventional, multi-centre, registry of male and female patients with TTS who undergo follow-up echocardiography after the index event.
Rationale This large global registry focuses on long-term findings in TTS patients. The registry is observational, and decisions on patient management are determined by the health care professional and the patient and not by the protocol. Patients are therefore treated according to normal local practice.
Source Data: Data will be derived from the patients clinical records according to specifications outlined in the electronic case report form. This Registry will not undertake any experimental intervention with patients being treated according to normal local practice. No additional tests or procedures are required by the protocol. Physicians involved in initial diagnosis of TTS in patients may transfer or refer the cases to other physicians who will treat and follow up the patients in the long-term.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- Echocardiography
- Keywords
- syndrome
- Medical subject headings
- Takotsubo Cardiomyopathy, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Patients will undergo Doppler echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic dysfunction
The time to the echocardiographic finding of left ventricular systolic dysfunction
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Feb 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Carlo Gaudio, MD, Study chair, University Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084157
- Sponsor's protocol ID
- D-21-1111
- Acronym
- LONG-TAKE
- Status last verified
- Jan 2022
- First submitted
- 5 Oct 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, International, Registry of LONG-term Findings at Cardiac Imaging in TAKotsubo SyndromE (The LONG-TAKE Registry)
- ClinicalTrials.gov ID
- NCT05084157
- Acronym / sponsor ID
- LONG-TAKE / D-21-1111
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 19 Oct 2021 (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.
Takotsubo syndrome (TTS) is characterized by severe left ventricular (LV) dysfunction that gradually recovers, thus leading to the commonly accepted belief that it is a transient and self-limiting condition.
Histologically, TTS can be accompanied by severe morphological alterations potentially resulting from catecholamine excess followed by microcirculatory dysfunction and direct cardiotoxicity. The affected myocardium, however, has a high potential of structural reconstitution which correlates with the rapid functional recovery. The lack of persistent morphological changes in TTS has been confirmed by original CMR studies which pointed out that the acute phase of the disease is characterized only by remarkable myocardial edema with no evidence of significant late gadolinium enhancement. Indeed, the absence of LGE in TTS patients has become a common diagnostic criterion in most CMR centers. Although some studies have challenged this notion by reporting delayed hyper-enhancement in TTS patients, the intensity and extent of LGE in the acute phase of TTS are less than usually reported in studies of myocardial infarction.
The long-term clinical and functional consequences of an acute episode of TTS are still unclear. A recent spectroscopic investigation has shown that long-term (>1 year) abnormalities in cardiac energetic persist after an acute episode of TTS. Also, a few patients with residual wall motion abnormality in whom LGE fails to resolve (suggesting the acute event resulted in frank infarction) have been reported. However, how often persistent morphologic abnormalities are present after the index episode remains undefined. The possibility exists that fibrosis was undetected at follow-up CMR studies using conventional LGE threshold methods due to the fact that myocardial injury is subtler and there are no confidently recognizable reference regions of normal myocardium. Newer echocardiographic tools (i.e. tissue Doppler) have now the potential to detect persistence of post-TTS LV function abnormalities.
Detailed description
Objective of the study The aim of this study is to assess the frequency of long-term (>12 months) morphologic abnormalities at cardiac imaging after an index episode of TTS, and their possible correlation with presenting features and long-term outcome
Study Population The registry will enrol consecutive patients with TS who have undergone echocardiography either at entry and during follow-up (>12 months).
Registry Design This is a non-interventional, multi-centre, registry of male and female patients with TTS who undergo follow-up echocardiography after the index event.
Rationale This large global registry focuses on long-term findings in TTS patients. The registry is observational, and decisions on patient management are determined by the health care professional and the patient and not by the protocol. Patients are therefore treated according to normal local practice.
Source Data: Data will be derived from the patients clinical records according to specifications outlined in the electronic case report form. This Registry will not undertake any experimental intervention with patients being treated according to normal local practice. No additional tests or procedures are required by the protocol. Physicians involved in initial diagnosis of TTS in patients may transfer or refer the cases to other physicians who will treat and follow up the patients in the long-term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as having Takotsubo Syndrome on the basis of Mayo Criteria
Key inclusion criteria (3 listed)
- Diagnosis of TTS according to current International consensus criteria
- Written informed consent
- Age 18 years and over
Key exclusion criteria (2 listed)
- Secondary form of TTS (e.g. as it can occur after sepsis, neurological disorders, pheochromocytoma)
- Durg-induced form of TTS (e.g. after administration of drugs such as dopamine, dobutamine, epinephrine, or norepinephrine)
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 |
|---|---|---|
| EchocardiographyPatients will undergo Doppler echocardiography | Diagnostic test | – |
Primary outcome
Left ventricular systolic dysfunction
Time frame: Up to 5 years
The time to the echocardiographic finding of left ventricular systolic dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Takotsubo Cardiomyopathy
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Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
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Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
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Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
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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. This study is not recruiting at the moment.
Carlo Gaudio, MD study chair
University Sapienza
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Cardiomyopathy, run by University of Roma La Sapienza.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+39064997 ext. 123, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic dysfunction (time frame: Up to 5 years). 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 25 Jan 2022.