NCT03726528

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

5.1 years

First QC Date

October 1, 2018

Last Update Submit

October 17, 2022

Conditions

Takotsubo Syndrome

Outcome Measures

Primary Outcomes (7)

  • Changes in contractility derived from pressure-volume measurements

    systolic/diastolic pressure-volume relationship (mmHg/ml)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    peak-power index (mmHG/s)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    peak filling rate (ml/s)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    stroke work (mmHG x ml)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    relaxation constant "Tau" (ms)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    time to Emax (ms)

    Day 0

  • Changes in contractility derived from pressure-volume measurements

    max/min rate of left ventricular pressure change (mmHg/s)

    Day 0

Secondary Outcomes (7)

  • Energetic parameters derived from pressure-volume measurements

    Day 0

  • Energetic parameters derived from pressure-volume measurements

    Day 0

  • Afterload parameters derived from pressure-volume measurements

    Day 0

  • Afterload parameters derived from pressure-volume measurements

    Day 0

  • Afterload parameters derived from pressure-volume measurements

    Day 0

  • +2 more secondary outcomes

Study Arms (1)

Experimental intervention

EXPERIMENTAL
Diagnostic Test: Measurements of left ventricular pressure and volume

Interventions

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.

Experimental intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cardiogenic shock
  • Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
  • Pregnancy
  • Participation in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical clinic II-UKSH

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37197841DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular Dysfunction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 31, 2018

Study Start

September 1, 2017

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

DE(1)