Clinical Trial: Adenosin to Rapidly Reverse Left Ventricle Impairment in Takotsubo Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Rapid Recovery of Left Ventricular Function in Patients With Takotsubo Syndrome Undergoing Systemic Infusion of Adenosine: a Randomized Controlled Trial (TITAN Study)

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.

Detailed Summary:

Takotsubo syndrome is a heart condition that is characterized by the rapid onset of left ventricular dysfunction, usually reversible, and meeting the following diagnostic criteria:

  • Transient alterations of regional contractility of the myocardial wall of the right or left ventricle, which are frequently, but not always, preceded by a stressful event (emotional or physical).
  • The regional changes in contractility of the myocardial wall, often extend beyond the distribution of a single coronary vessel, and often result in a circumferential ventricular dysfunction of the involved segments.
  • Absence of a culprit coronary lesion (eg. Of atherosclerotic plaque rupture, thrombus formation, coronary dissection) or other pathological conditions that may explain the regional changes in contractility of the myocardial wall (eg. Hypertrophic cardiomyopathy, viral myocarditis)
  • Reversible electrocardiographic abnormalities of the EKG (ST-T segment elevation or depression, new onset of left bundle branch block, inversion of t wave and / or QTc elongation) during the acute phase (3 months).
  • Significant increase in serum natriuretic peptide (BNP or NT-proBNP) during the acute phase
  • Troponin significant increase, but relatively small, (disparity between the degree of left ventricular dysfunction and the value of troponin).
  • The recovery of left ventricular function during follow-up (3-6 months).

Epidemiology Since the Takotsubo syndrome has been described for the first time in 1991, its incidence, with the passing of years has been increasing, thanks to the possibility with networks for the treatmen
Sponsor: University Hospital of Ferrara

Current Primary Outcome: left ventricle ejection fraction (%) [ Time Frame: 48 hours ]

an indipendent corelab will review all images from 48-hour ecocardiography to establish LVEF value (%)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University Hospital of Ferrara

Dates:
Date Received: August 10, 2016
Date Started: August 2016
Date Completion: January 2018
Last Updated: August 13, 2016
Last Verified: August 2016