The Role of Sympathetic Tone Regarding the Anatomical and Functional Recovery of the Left Ventricle in TakoTsubo Syndrome

Summary

TakoTsubo Syndrome (TTS) constitutes an increasingly recognised, heterogenous clinical entity which is associated with considerable short-term mortality. In addition, emerging evidence suggests that, in the long term, TTS can induce the expression of a phenotype similar to HFpEF . Apart from the typical (apical left ventricular) type, the current TTS definition has been expanded to also include the mid-ventricular, the basal and the focal type. Several previous studies on the typical form of the syndrome demonstrated that the principal underlying pathophysiology is sympathetic overactivation.

Purpose The aim of this study is to investigate the potential association between the sympathetic tone and the acute phase clinical features of TTS. Furthermore, the investigators aim at exploring possible correlations between the sympathetic tone activity and the diastolic dysfunction, a reported complication occurring one year after the acute phase.

This is a prospective observational study enrolling patients aged 18-85 years who fulfill the InterTaK diagnostic criteria and whose CMR within 14 days of the onset is not suggestive of an alternative diagnosis. All patients will be treated on individual basis according to the recent expert consensus statement for TTS. During the baseline evaluation the sympathetic tone will be assessed by means of Muscle Sympathetic Nerve Activity study (MSNA), heart rate and blood pressure variability parameters. Additionally, in a subgroup of participants sympathetic activity and cardiac sympathetic enervation will be evaluated with radioactive Iodine Metaiodobenzylguanidine scintigraphy (mIBG). Sequential echocardiography and CMR indices will be used for heart function and geometry assessment. The investigators will investigate the correlation between the sympathetic tone and the severity of cardiac dysfunction (systolic and diastolic) during the acute phase. Furthermore, the investigators will examine differences of the sympathetic tone effect in association with the localisation of the wall motion abnormality. Stress levels and quality of life will be assessed with respective validated questionnaires. The participants will be followed-up with quarterly clinic reviews for 12 months after the acute event. Baseline measurements will be repeated at the end of the follow-up period. Ethics approval has been obtained from the hospital ethical committee board.

The study results are expected to determine the role of the sympathetic tone on the extend, the severity and the localisation of cardiac dysfunction during the acute phase. They are also expected to demonstrate the role of the sympathetic tone on the long-lasting disorder that persists for months following the acute event.

Conditions

• Takotsubo Cardiomyopathy

Interventions

DIAGNOSTIC_TEST

123 MIBG scintigraphy testing

123 MIBG scintigraphy testing in subacute phase and 12 months after the acute episode in a subgroup of patients according to individualized needs.

DIAGNOSTIC_TEST

MSNA

MSNA in subacute phase and 12 months after the acute episode

DIAGNOSTIC_TEST

ABPM

ABPM in subacute phase and 12 months after the acute episode

DIAGNOSTIC_TEST

ECHO

ECHO in subacute phase and 12 months after the acute episode

DIAGNOSTIC_TEST

24hour ECG

24hour ECG in subacute phase and 12 months after the acute episode

DIAGNOSTIC_TEST

CMR

CMR in 12 months after the acute episode

Sponsors & Collaborators

• Naval Hospital, Athens

  collaborator OTHER

• General Hospital of Athens Elpis

  collaborator OTHER

• 401 General Military Hospital of Athens

  collaborator OTHER

• 251 Hellenic Air Force & VA General Hospital

  collaborator OTHER

• Evangelismos Hospital

  collaborator OTHER

• Alexandra Hospital, Athens, Greece

  collaborator OTHER

• Sismanoglio General Hospital

  collaborator OTHER

• G.Gennimatas General Hospital

  collaborator OTHER

• Laikο General Hospital, Athens

  collaborator OTHER

• Tzaneio General Hospital

  collaborator OTHER

• Thriasio General Hospital of Elefsina

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• Hippocration General Hospital

  lead OTHER

Principal Investigators

• Konstantinos P Tsioufis, Professor · 1st Cardiolgogy Clinic, Hippocratio General Hospital of Athens, National and Kapodistrian University of Athens, Greece

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-08

Primary Completion

2022-10-07

Completion

2023-10-07

Countries

• Greece

Study Locations