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OpenTrials
Completed

NCT Number: NCT04684004

Hyperglycemia in Patients With Takotsubo Syndrome

Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Raffaele Marfella

Naples, 80138, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;
  • cardiac biomarker modifications (creatine kinase-MB and troponin I);
  • systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.

Exclusion criteria

  • patients with previous previous myocardial infarction;
  • patients with previous TTC event;
  • patients affected by chronic kidney, liver, and cerebrovascular diseases.

Treatment and study plan

To report number of HF events and deaths

Other

In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.

Primary outcomes

  1. The number of HF events

    Time frame: 12 months

    To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Dec 24, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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