Hyperglycemia in Patients With Takotsubo Syndrome

NCT04684004 | Completed

• 1 other identifier: 02.12.20
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• The number of HF events

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

  12 months

Study Arms (2)

TTC patients with hyperglycemia

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.

Other: To report number of HF events and deaths

TTC patients with normoglycemia

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.

Other: To report number of HF events and deaths

Interventions

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.

TTC patients with hyperglycemia; TTC patients with normoglycemia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80138, Italy

Location

Related Publications (1)

• Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.

  PMID: 34187841 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Death Domain

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Death Domain Superfamily; Protein Interaction Domains and Motifs; Protein Domains; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2019
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

IT (1)