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

October 17, 2022 updated by: Prof. Dr. med. Ingo Eitel, University of Luebeck
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23562
        • Medical clinic II-UKSH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
systolic/diastolic pressure-volume relationship (mmHg/ml)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
peak-power index (mmHG/s)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
peak filling rate (ml/s)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
stroke work (mmHG x ml)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
relaxation constant "Tau" (ms)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
time to Emax (ms)
Day 0
Changes in contractility derived from pressure-volume measurements
Time Frame: Day 0
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
Time Frame: Day 0
stroke work, potential energy (mmHg x ml)
Day 0
Energetic parameters derived from pressure-volume measurements
Time Frame: Day 0
total pressure volume area (mmHg/ml)
Day 0
Afterload parameters derived from pressure-volume measurements
Time Frame: Day 0
arterial elastance (mmHg/ml)
Day 0
Afterload parameters derived from pressure-volume measurements
Time Frame: Day 0
ventricular arterial coupling (no dimension)
Day 0
Afterload parameters derived from pressure-volume measurements
Time Frame: Day 0
total arterial compliance (mmHg/ml)
Day 0
- Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging
Time Frame: Day 3
(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
Time Frame: Day 0
(troponin, NT-proBNP)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

October 7, 2022

Study Completion (ACTUAL)

October 7, 2022

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (ACTUAL)

October 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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