Hyperglycemia in Patients With Takotsubo Syndrome

Completed

• Conditions: Takotsubo Cardiomyopathy
• Interventions: Other: To report number of HF events and deaths

• Registration Number: NCT04684004
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2019-01-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TTC patients with normoglycemia	To report number of HF events and deaths	These patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics.
TTC patients with hyperglycemia	To report number of HF events and deaths	These patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics.

Primary Outcome Measures

Name	Time	Method
The number of HF events	12 months	To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.

Trial Locations

Locations (1)

Raffaele Marfella; 🇮🇹 Naples, Italy