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
NCT number | NCT04684004 |
Other study ID # | 02.12.20 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2013 |
Est. completion date | January 1, 2019 |
Verified date | December 2020 |
Source | University of Campania "Luigi Vanvitelli" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 1, 2019 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Raffaele Marfella | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
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 |
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