Adenosin to Rapidly Reverse Left Ventricle Impairment in Takotsubo Syndrome

NCT02867878 | Terminated Phase 2 DMC

• 1 other identifier: 160596
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Cardiomyopathy; Takotsubo Syndrome

Outcome Measures

Primary Outcomes (1)

• left ventricle ejection fraction (%)

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

  48 hours

Secondary Outcomes (12)

• left ventricle ejection fraction (%)

  24 hours

• left ventricle ejection fraction (%)

  1 month

• wall motion score index

  24 hours

• wall motion score index

  48 hours

• wall motion score index

  1 month

Study Arms (2)

Adenosine

EXPERIMENTAL

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

Saline solution

PLACEBO COMPARATOR

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

Interventions

Adenosine DRUG

Adenosine

Saline solution DRUG

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Adenosine; Saline Solution

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Matteo Tebaldi, MD

  Azienda Ospedaliera Universitria di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

IT (1)