The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum age 18 years

Established TTS per InterTak registry criteria

Signed consent form

Disqualifiers

Patients under the age of 18 years

Ischemic heart disease with at least one complete total occlusion

Other concurrent cardiomyopathies

Active infectious myocarditis

Trial population

Adult patients, predominantly females, with cardiovascular risk factors.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Takotsubo patients with preserved OR mildly reduced/reduced LVEF at acute event.

Trial outcomes

Primary outcomes

1

Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)

Change in LVEF (%), measured by transthoracic echocardiography using Biplane Simpson's method.

Time frame
From enrollment to the end of observational period at 6-month follow-up.

Secondary outcomes

1

Improvement in myocardial contractility and deformation assesed by change in left ventricular global longitudinal strain (LV GLS)

Change in LV GLS (%), measured by transthoracic echocardiography using speckle-tracking method.

Time frame
From enrollment to the end of observational period at 6-month follow-up.
2

Reduction in left ventricular filling pressure assessed by change in early mitral inflow velocity (E-wave) and the average of the septal and lateral early diastolic mitral annular velocities ratio (E/e' average)

Change in E/e' average, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the average of the septal and lateral early diastolic mitral annular velocities (e') obtained via tissue doppler imaging.

Time frame
From enrollment to the end of observational period at 6-month follow-up.
3

Recovery of impaired myocardial relaxation assessed by change in peak early mitral inflow velocity and peak atrial contraction wave velocity ratio (E/A ratio)

Change in E/A ratio, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the peak atrial contraction velocity (A-wave), both measured via pulsed-wave Doppler in the apical four-chamber view.

Time frame
From enrollment to the end of observational period at 6-month follow-up.
4

Reduction in pulmonary artery systolic pressure assessed by change in tricuspid regurgitation maximum gradient (TR max gradient)

Change in TR max gradient (mmHg), measured using transthoracic echocardiography by applying continuous wave (CW) doppler to the TR jet to determine the peak velocity, then applying the modified Bernoulli equation.

Time frame
From enrollment to the end of observational period at 6-month follow-up.

Other outcomes

Sponsors and contacts

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