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Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03726528
Acronym
OCTOPUS
Enrollment
25
Registered
2018-10-31
Start date
2017-09-01
Completion date
2022-10-07
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Syndrome

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

Interventions

DIAGNOSTIC_TESTMeasurements 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.

Sponsors

University of Luebeck
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in contractility derived from pressure-volume measurementsDay 0systolic/diastolic pressure-volume relationship (mmHg/ml)

Secondary

MeasureTime frameDescription
Energetic parameters derived from pressure-volume measurementsDay 0stroke work, potential energy (mmHg x ml)
Afterload parameters derived from pressure-volume measurementsDay 0arterial elastance (mmHg/ml)
- Correlation of pressure-volume measurements with morphological and functional findings in CMR imagingDay 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 releaseDay 0(troponin, NT-proBNP)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026