Cardiac Autonomic Dysfunction in Diabetics Patients With Syncope
SGLT2-inhibitors Reduce the Cardiac Autonomic Neuropathy Dysfunction and Vaso-vagal Syncope Recurrence in Patients With Type 2 Diabetes Mellitus: the SCAN Study
1 other identifier
observational
242
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMay 6, 2022
April 1, 2022
6 years
October 22, 2018
April 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
syncope recurrence
authors will report all syncope recurrences at 12 months of follow up in T2DM patients SGLT-I users vs. T2DM patients Non-SGLT2-I users.
12 months.
Study Arms (2)
type 2 diabetes mellitus (T2DM) patients under SGLT2-I therapy (SGLT2-I users)
T2DM patients affected by vaso vagal syncope, and under SGLT2-I therapy. All these patients were in stable sinus rate before performing the HUT They performed a 24 hours ECG Holter to assess sinus rhythm, HR, HRV, and the MIBG myocardial scintigraphy before receiving a HUT. .
type 2 diabetes mellitus (T2DM) patients without SGLT2-I therapy (Non-SGLT2-I users)
T2DM patients affected by vaso vagal syncope, and without SGLT2-I therapy. All these patients were in stable sinus rate before performing the HUT They performed a 24 hours ECG Holter to assess sinus rhythm, HR, HRV, and the MIBG myocardial scintigraphy before receiving a HUT.
Interventions
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.
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.
Eligibility Criteria
Included patients with clinical history of vaso vagal syncope, as diagnosed by head up tilt test. These patients, aged between 18 and 75 years, received an ecg Holter before to perform head up tilt test evaluation. These patients presented with vaso vagal syncope in absence of neuropathy, arterial hypertension, heart failure and coronary heart disease or depression of left ventricle ejection fraction (LVEF \< 55%).
You may qualify if:
- patients with diagnosis of vaso vagal syncope, and left ventricle ejection fraction \>55%.
You may not qualify if:
- patients with neuropathy, arterial hypertension, indications of heart failure and coronary heart disease or depression of left ventricle ejection fraction (LVEF \< 55%).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raffaele Marfella
Naples, 80138, Italy
Related Publications (1)
Sardu C, Massimo Massetti M, Rambaldi P, Gatta G, Cappabianca S, Sasso FC, Santamaria M, Volpicelli M, Ducceschi V, Signoriello G, Paolisso G, Marfella R. SGLT2-inhibitors reduce the cardiac autonomic neuropathy dysfunction and vaso-vagal syncope recurrence in patients with type 2 diabetes mellitus: the SCAN study. Metabolism. 2022 Dec;137:155243. doi: 10.1016/j.metabol.2022.155243. Epub 2022 Jun 19.
PMID: 35732222DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
October 22, 2018
First Posted
October 24, 2018
Study Start
January 1, 2010
Primary Completion
January 1, 2016
Study Completion
March 1, 2021
Last Updated
May 6, 2022
Record last verified: 2022-04