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Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops (OCTOPUS)

Primary Purpose

Takotsubo Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Measurements of left ventricular pressure and volume
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Takotsubo Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical clinic II-UKSH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental intervention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Energetic parameters derived from pressure-volume measurements
stroke work, potential energy (mmHg x ml)
Energetic parameters derived from pressure-volume measurements
total pressure volume area (mmHg/ml)
Afterload parameters derived from pressure-volume measurements
arterial elastance (mmHg/ml)
Afterload parameters derived from pressure-volume measurements
ventricular arterial coupling (no dimension)
Afterload parameters derived from pressure-volume measurements
total arterial compliance (mmHg/ml)
- 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)
- Correlation of pressure-volume measurements with biomarker release
(troponin, NT-proBNP)

Full Information

First Posted
October 1, 2018
Last Updated
October 17, 2022
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT03726528
Brief Title
Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
Acronym
OCTOPUS
Official Title
Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental intervention
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurements of left ventricular pressure and volume
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in contractility derived from pressure-volume measurements
Description
systolic/diastolic pressure-volume relationship (mmHg/ml)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
peak-power index (mmHG/s)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
peak filling rate (ml/s)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
stroke work (mmHG x ml)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
relaxation constant "Tau" (ms)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
time to Emax (ms)
Time Frame
Day 0
Title
Changes in contractility derived from pressure-volume measurements
Description
max/min rate of left ventricular pressure change (mmHg/s)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Energetic parameters derived from pressure-volume measurements
Description
stroke work, potential energy (mmHg x ml)
Time Frame
Day 0
Title
Energetic parameters derived from pressure-volume measurements
Description
total pressure volume area (mmHg/ml)
Time Frame
Day 0
Title
Afterload parameters derived from pressure-volume measurements
Description
arterial elastance (mmHg/ml)
Time Frame
Day 0
Title
Afterload parameters derived from pressure-volume measurements
Description
ventricular arterial coupling (no dimension)
Time Frame
Day 0
Title
Afterload parameters derived from pressure-volume measurements
Description
total arterial compliance (mmHg/ml)
Time Frame
Day 0
Title
- Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging
Description
(presence of myocardial edema or late gadolinium enhancement, native T1 time, myocardial strain assessed by CMR feature tracking)
Time Frame
Day 3
Title
- Correlation of pressure-volume measurements with biomarker release
Description
(troponin, NT-proBNP)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical clinic II-UKSH
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23562
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

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