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

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 |

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
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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
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Drug: Saline solution |
- left ventricle ejection fraction (%) [ Time Frame: 48 hours ]an indipendent corelab will review all images from 48-hour ecocardiography to establish LVEF value (%)
- left ventricle ejection fraction (%) [ Time Frame: 24 hours ]an indipendent corelab will review all images from 24-hour ecocardiography to establish LVEF value (%)
- left ventricle ejection fraction (%) [ Time Frame: 1 month ]an indipendent corelab will review all images from 1-month ecocardiography to establish LVEF value (%)
- wall motion score index [ Time Frame: 24 hours ]an indipendent corelab will review all images from 24-hour ecocardiography to calculate WMSI value (number)
- wall motion score index [ Time Frame: 48 hours ]an indipendent corelab will review all images from 48-hour ecocardiography to calculate WMSI value (number)
- wall motion score index [ Time Frame: 1 month ]an indipendent corelab will review all images from 1-month ecocardiography to calculate WMSI value (number)
- acute heart failure [ Time Frame: 1 month ]it is defined as dyspnea + crackles on auscultation + signs on X-ray of chest congestion
- intravenous diuretics [ Time Frame: 1 month ]it is defined as the total count of mg of furosemide
- emergency room admission [ Time Frame: 1 month ]Access to the emergency room for dyspnea/heart failure
- major adverse events [ Time Frame: 1 year ]cumulative incidence of all-cause death and hospital admission for cardiovascular causes
- 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
- arterial hypotension [ Time Frame: 1 hour ]persistent hypotension (arterial blood pressure <90 mmHg) during administration of adenosine as shown by invasive blood pressure recording
- 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 |
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)

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
Italy | |
University Hospital of Ferrara | |
Cona, Ferrara, Italy, 44124 |
Principal Investigator: | Matteo Tebaldi, MD | Azienda Ospedaliera Universitria di Ferrara |
Responsible Party: | Gianluca Campo, Associate Professor, University Hospital of Ferrara |
ClinicalTrials.gov Identifier: | NCT02867878 |
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 |
Adenosine Cardiomyopathies Takotsubo Cardiomyopathy Syndrome Disease Pathologic Processes Heart Diseases Cardiovascular Diseases Ventricular Dysfunction, Left Ventricular Dysfunction 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 |