Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Study Overview
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Brief Summary
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Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms

Official Title
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Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Conditions
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Takotsubo Syndrome

Intervention / Treatment
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* Diagnostic Test: Measurements of left ventricular pressure and volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up Sinus rhythm during invasive measurements Age ≥18 years Written informed consent Exclusion Criteria: Cardiogenic shock Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging Pregnancy Participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental intervention<br> | Diagnostic Test: Measurements of left ventricular pressure and volume<br>* Patients with suspected Takotsubo syndrome (typical ballooning in left ventriculography without significant obstructive coronary artery disease that sufficiently explains the contraction abnormalities) will undergo continuous online measurements of left ventricular pressure and volume using conductance catheters. Cardiac magnetic resonance (CMR) imaging will be performed in patients without contraindications for optimized morphological characterization and exclusion of important differential diagnoses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in contractility derived from pressure-volume measurements | systolic/diastolic pressure-volume relationship (mmHg/ml) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | peak-power index (mmHG/s) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | peak filling rate (ml/s) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | stroke work (mmHG x ml) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | relaxation constant Tau (ms) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | time to Emax (ms) | Day 0 | 
| Changes in contractility derived from pressure-volume measurements | max/min rate of left ventricular pressure change (mmHg/s) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energetic parameters derived from pressure-volume measurements | stroke work, potential energy (mmHg x ml) | Day 0 | 
| Energetic parameters derived from pressure-volume measurements | total pressure volume area (mmHg/ml) | Day 0 | 
| Afterload parameters derived from pressure-volume measurements | arterial elastance (mmHg/ml) | Day 0 | 
| Afterload parameters derived from pressure-volume measurements | ventricular arterial coupling (no dimension) | Day 0 | 
| Afterload parameters derived from pressure-volume measurements | total arterial compliance (mmHg/ml) | Day 0 | 
| - Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging | (presence of myocardial edema or late gadolinium enhancement, native T1 time, myocardial strain assessed by CMR feature tracking) | Day 3 | 
| - Correlation of pressure-volume measurements with biomarker release | (troponin, NT-proBNP) | Day 0 |