Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Not Applicable

Completed

• Conditions: Takotsubo Syndrome
• Interventions: Diagnostic Test: Measurements of left ventricular pressure and volume

• Registration Number: NCT03726528
• Lead Sponsor: University of Luebeck

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Status Verified: 2022-10
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental intervention	Measurements of left ventricular pressure and volume	-

Primary Outcome Measures

Name	Time	Method
Changes in contractility derived from pressure-volume measurements	Day 0	max/min rate of left ventricular pressure change (mmHg/s)

Secondary Outcome Measures

Name	Time	Method
Energetic parameters derived from pressure-volume measurements	Day 0	total pressure volume area (mmHg/ml)
Afterload parameters derived from pressure-volume measurements	Day 0	total arterial compliance (mmHg/ml)
- Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging	Day 3	(presence of myocardial edema or late gadolinium enhancement, native T1 time, myocardial strain assessed by CMR feature tracking)
- Correlation of pressure-volume measurements with biomarker release	Day 0	(troponin, NT-proBNP)

Trial Locations

Locations (1)

Medical clinic II-UKSH; 🇩🇪 Luebeck, Schleswig-Holstein, Germany