Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Takotsubo Syndrome Clinical Trial

— OCTOPUS  

Official title:

Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726528
• Other study ID #: 17-078
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 7, 2022

Study information

• Verified date: October 2022
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Takotsubo Cardiomyopathy
• Takotsubo Syndrome

Intervention

Diagnostic Test:
• Measurements of left ventricular pressure and volume
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.

Locations

Country	Name	City	State
Germany	Medical clinic II-UKSH	Luebeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in contractility derived from pressure-volume measurements	systolic/diastolic pressure-volume relationship (mmHg/ml)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	peak-power index (mmHG/s)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	peak filling rate (ml/s)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	stroke work (mmHG x ml)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	relaxation constant "Tau" (ms)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	time to Emax (ms)	Day 0
Primary	Changes in contractility derived from pressure-volume measurements	max/min rate of left ventricular pressure change (mmHg/s)	Day 0
Secondary	Energetic parameters derived from pressure-volume measurements	stroke work, potential energy (mmHg x ml)	Day 0
Secondary	Energetic parameters derived from pressure-volume measurements	total pressure volume area (mmHg/ml)	Day 0
Secondary	Afterload parameters derived from pressure-volume measurements	arterial elastance (mmHg/ml)	Day 0
Secondary	Afterload parameters derived from pressure-volume measurements	ventricular arterial coupling (no dimension)	Day 0
Secondary	Afterload parameters derived from pressure-volume measurements	total arterial compliance (mmHg/ml)	Day 0
Secondary	- 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
Secondary	- Correlation of pressure-volume measurements with biomarker release	(troponin, NT-proBNP)	Day 0