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Cardiac Autonomic Dysfunction in Diabetics Patients With Syncope

NCT03717207 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2022-05-06

No results posted yet for this study

Summary

Study hypothesis: cardiac autonomic dysfunction may affect vaso vagal syncope recurrences in type 2 patients with diabetes vs. patients without diabetes.

Background: vaso vagal syncope and its recurrences may be due to alterations in autonomic system function, that may be more frequent in diabetics. Heart rate variability (HRV) is a valid test to study sympathetic and vaso vagal tone dysfunction. However, in this study authors investigated the correlation between HRV alterations and diabetes in a population of patients affected by syncope, and classified as vaso vagal syncope by Head Up Tilt Test (HUT) exam. Secondly, authors assessed these alterations as causes of vaso vagal syncope recurring at 12 months of follow up in type 2 patients with diabetes under sodium-glucose transporter 2 inhibitors (SGLT2-inhibitors) vs. other hypoglycemic drugs .. Materials and Methods: In a multicenter study authors studied T2DM patients under SGLT2-I therapy (n 426) vs. those that did not receive the SGLT2-I therapy (n 2195), and affectede by vaso vagal syncope. All enrolled patients were in stable sinus rate before to perform ECG Holter, and the Head Up Tilt Test (HUT). However, before to perform the HUT all patients performed a 24 hours ECG Holter, to asses sinus rhythm , heart rate, and HRV. Then, these patients performed a 123I-metaiodobenzylguanidine (123I-MIBG) myocardial scintigraphy to assess cardiac autonomic dysfunction.

Moreover, authors performed a propensity score matching (PSM) analysis to evaluate 160 SGLT2-I users vs. 160 Non-SGLT2-I users' patients.

Conditions

  • Syncope, Vasovagal

Interventions

OTHER

ecg Holter,

all patients before to perform an head up tilt test for syncope evaluation will be steadied by ecg Holter to assess heart rate, heart rate variability.

DIAGNOSTIC_TEST

cardiac scintigraphy

all patients before to perform an head up tilt test for syncope evaluation will receive a the 123I-MIBG, which is a norepinephrine analogous, to calculate the late heart-to-mediastinum ratio (H/Mlate) and washout rate (WR). Thus, we evaluated the H/Mlate as the index of global neuronal function due to norepinephrine uptake and the WR as the index of sympathetic tone.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2016-01-01
Completion
2021-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03717207 on ClinicalTrials.gov