Takotsubo SyndromeOCTOPUSNCT03726528
Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
A study testing Measurements of left ventricular pressure and volume in people with Takotsubo Syndrome, run by University of Luebeck at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Syndrome
- What is being tested?
- Measurements of left ventricular pressure and volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiogenic shock
- Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
- Pregnancy
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Takotsubo Syndrome
- Being tested
- Measurements of left ventricular pressure and volume
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of left ventricular pressure and volumeDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | Not described Receives: Diagnostic Test: Measurements of left ventricular pressure and volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in contractility derived from pressure-volume measurements
systolic/diastolic pressure-volume relationship (mmHg/ml)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
peak-power index (mmHG/s)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
peak filling rate (ml/s)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
stroke work (mmHG x ml)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
relaxation constant "Tau" (ms)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
time to Emax (ms)
Measured: Day 0
Changes in contractility derived from pressure-volume measurements
max/min rate of left ventricular pressure change (mmHg/s)
Measured: Day 0
Secondary outcomes (7)
Energetic parameters derived from pressure-volume measurements
stroke work, potential energy (mmHg x ml)
Measured: Day 0
Energetic parameters derived from pressure-volume measurements
total pressure volume area (mmHg/ml)
Measured: Day 0
Afterload parameters derived from pressure-volume measurements
arterial elastance (mmHg/ml)
Measured: Day 0
Afterload parameters derived from pressure-volume measurements
ventricular arterial coupling (no dimension)
Measured: Day 0
Afterload parameters derived from pressure-volume measurements
total arterial compliance (mmHg/ml)
Measured: Day 0
- 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)
Measured: Day 3
- Correlation of pressure-volume measurements with biomarker release
(troponin, NT-proBNP)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Sep 2017
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takotsubo SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726528
- Sponsor's protocol ID
- 17-078
- Acronym
- OCTOPUS
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2018
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stiermaier T, Reil JC, Sequeira V, Rawish E, Mezger M, Patz T, Paitazoglou C, Schmidt T, Frerker C, Steendijk P, Reil GH, Eitel I. Hemodynamic Assessment in Takotsubo Syndrome. J Am Coll Cardiol. 2023 May 23;81(20):1979-1991. doi: 10.1016/j.jacc.2023.03.398.
PubMed 37197841
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops
- ClinicalTrials.gov ID
- NCT03726528
- Acronym / sponsor ID
- OCTOPUS / 17-078
- Conditions
- Takotsubo Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Diagnostic Test: Measurements of left ventricular pressure and volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Cardiogenic shock
- Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
- Pregnancy
- Participation in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of left ventricular pressure and volumePatients 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. | Diagnostic test | Experimental intervention |
Primary outcome
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
systolic/diastolic pressure-volume relationship (mmHg/ml)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
peak-power index (mmHG/s)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
peak filling rate (ml/s)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
stroke work (mmHG x ml)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
relaxation constant "Tau" (ms)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
time to Emax (ms)
Changes in contractility derived from pressure-volume measurements
Time frame: Day 0
max/min rate of left ventricular pressure change (mmHg/s)
7 secondary outcomes
Energetic parameters derived from pressure-volume measurements
Time frame: Day 0
Energetic parameters derived from pressure-volume measurements
Time frame: Day 0
Afterload parameters derived from pressure-volume measurements
Time frame: Day 0
Afterload parameters derived from pressure-volume measurements
Time frame: Day 0
Afterload parameters derived from pressure-volume measurements
Time frame: Day 0
- Correlation of pressure-volume measurements with morphological and functional findings in CMR imaging
Time frame: Day 3
- Correlation of pressure-volume measurements with biomarker release
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 37197841Stiermaier T, Reil JC, Sequeira V, Rawish E, Mezger M, Patz T, Paitazoglou C, Schmidt T, Frerker C, Steendijk P, Reil GH, Eitel I. Hemodynamic Assessment in Takotsubo Syndrome. J Am Coll Cardiol. 2023 May 23;81(20):1979-1991. doi: 10.1016/j.jacc.2023.03.398.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of left ventricular pressure and volume in people with Takotsubo Syndrome, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in contractility derived from pressure-volume measurements (time frame: Day 0). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.