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Adenosin to Rapidly Reverse Left Ventricle Impairment in Takotsubo Syndrome (TITAN)

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ClinicalTrials.gov Identifier: NCT02867878
Recruitment Status : Terminated (inability to recruiti a sufficient number of patients)
First Posted : August 16, 2016
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

Brief Summary:
The investigators will randomize patients admitted to hospital with Takotsubo diagnosis to systematic high-dose adenosine infusion for 3 minutes (in addition to standard of care) vs. standard of care. The primary aim of the study is to demonstrate that adenosine infusion is associated with a larger and more rapid recovery of left ventricle function.

Condition or disease Intervention/treatment Phase
Takotsubo Cardiomyopathy Takotsubo Syndrome Drug: Adenosine Drug: Saline solution Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rapid Recovery of Left Ventricular Function in Patients With Takotsubo Syndrome Undergoing Systemic Infusion of Adenosine: a Randomized Controlled Trial (TITAN Study)
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: Adenosine
Patients in this arm will receive systemic infusion of adenosine at 140μg/kg/min for 3 minutes plus standard therapy according to current guidelines
Drug: Adenosine
Placebo Comparator: Saline solution
Patients in this arm will receive systemic infusion of saline solution at 140μg/kg/min for 3 minutes plus standard therapy according to current guidelines
Drug: Saline solution



Primary Outcome Measures :
  1. left ventricle ejection fraction (%) [ Time Frame: 48 hours ]
    an indipendent corelab will review all images from 48-hour ecocardiography to establish LVEF value (%)


Secondary Outcome Measures :
  1. left ventricle ejection fraction (%) [ Time Frame: 24 hours ]
    an indipendent corelab will review all images from 24-hour ecocardiography to establish LVEF value (%)

  2. left ventricle ejection fraction (%) [ Time Frame: 1 month ]
    an indipendent corelab will review all images from 1-month ecocardiography to establish LVEF value (%)

  3. wall motion score index [ Time Frame: 24 hours ]
    an indipendent corelab will review all images from 24-hour ecocardiography to calculate WMSI value (number)

  4. wall motion score index [ Time Frame: 48 hours ]
    an indipendent corelab will review all images from 48-hour ecocardiography to calculate WMSI value (number)

  5. wall motion score index [ Time Frame: 1 month ]
    an indipendent corelab will review all images from 1-month ecocardiography to calculate WMSI value (number)

  6. acute heart failure [ Time Frame: 1 month ]
    it is defined as dyspnea + crackles on auscultation + signs on X-ray of chest congestion

  7. intravenous diuretics [ Time Frame: 1 month ]
    it is defined as the total count of mg of furosemide

  8. emergency room admission [ Time Frame: 1 month ]
    Access to the emergency room for dyspnea/heart failure

  9. major adverse events [ Time Frame: 1 year ]
    cumulative incidence of all-cause death and hospital admission for cardiovascular causes

  10. hypokinetic arrhythmias [ Time Frame: 1 hour ]
    cumulative occurrence of hypokinetic arrhythmias (asystole, atrio-venticular block) in the course of administration of adenosine as shown by electrocardiogram recording

  11. arterial hypotension [ Time Frame: 1 hour ]
    persistent hypotension (arterial blood pressure <90 mmHg) during administration of adenosine as shown by invasive blood pressure recording

  12. side effects [ Time Frame: 1 hour ]
    Persistent symptoms (nausea, dyspnea, hot flush, etc.) that require premature discontinuation of the administration of adenosine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old
  • Evidence of typical anatomical pattern to the left ventriculography (total akinesia of the mid-apical segments with hypercontractility basal segments) associated with the presence of criteria for the diagnosis of Takotsubo syndrome (Table 1)
  • signing of informed consent

Exclusion Criteria:

  • allergy to adenosine
  • known and documented diagnosis of asthma
  • pre-existing ischemic heart disease
  • presence of arrhythmic complication (AV block grade II type 2 and third degree)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867878


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Matteo Tebaldi, MD Azienda Ospedaliera Universitria di Ferrara

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Responsible Party: Gianluca Campo, Associate Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT02867878     History of Changes
Other Study ID Numbers: 160596
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction
Adenosine
Pharmaceutical Solutions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action