Hyperglycemia in Patients With Takotsubo Syndrome

Takotsubo Cardiomyopathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684004
• Other study ID #: 02.12.20
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 1, 2019

Study information

• Verified date: December 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2017
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Hyperglycemia
• Takotsubo Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
Italy	Raffaele Marfella	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of HF events	To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.	12 months