Long-term Echocardiographic Findings in Takotsubo Syndrome (LONG-TAKE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Takotsubo Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Echocardiography

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Giuseppe Marazzi, MD; Phone Number: 345 +39064997; Email: marazzi.gius@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as having Takotsubo Syndrome on the basis of Mayo Criteria

Description

Inclusion Criteria:

• Diagnosis of TTS according to current International consensus criteria
• Written informed consent
• Age 18 years and over

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular systolic dysfunction	The time to the echocardiographic finding of left ventricular systolic dysfunction	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Chair: Carlo Gaudio, MD, University Sapienza

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: D-21-1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No