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Cardiac Autonomic Dysfunction in Diabetics Patients With Syncope

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ClinicalTrials.gov Identifier: NCT03717207
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

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 vs. patients without diabetes. Materials and Methods: In a retrospective multicenter study authors studied 1567 consecutive patients with 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. Moreover, authors performed a propensity score matching (PSM) analysis to evaluate 121 diabetics vs. 121 non diabetics.


Condition or disease Intervention/treatment
Syncope, Vasovagal Other: ecg Holter

Detailed Description:
Vaso vagal syncope recurrence is a relevant clinical problem (1). In fact, despite the vaso vagal syncope event is a transient loss of consciousness with rapid onset, short duration, and spontaneous complete recovery after the event, it may be complicated by physical injury (2). Conversely, the syncope recurrence rate is about 35%, and it causes a physical injury until the 29% (3). In addition, the vaso vagal syncope has a frequency between 15% and 39%, with annual number of episodes about 18.1-39.7 per 1000 patients, and an incidence of 6.2 per 1000 person-years, that grows up after 70 years of age with rate annual 19.5 per thousand individuals after 80 years (3). The patients with type 2 diabetes mellitus (T2DM) represent a percentage about the 30% of all the subjects with syncope (4). About the pathophysiology of syncope a central role is played by autonomic nervous system (5). To date, the autonomic nervous system regulates the hemodynamic stability by maintaining a stable blood pressure and heart rate under normal and abnormal physiologic conditions (5). Consequently, the dysfunction of this complex regulatory system, and of its interaction with sensor systems as baroreceptors, mechanoreceptors, chemoreceptors, may alter the vascular reactivity, leading to the clinical event and to future recurrences (5). Multiple factors affecting the autonomic system balance may trigger and cause a syncope event, as the result of an inappropriate response of the autonomic nervous system, with excessive vagal tone, and sympathetic tone withdrawal (2). In this setting, authors may note the diabetes as a common cause of autonomic system dysfunction (6). Moreover, T2DM may cause a severe form of autonomic system dysfunction affecting the cardiac autonomic regulation, and named as cardiac autonomic neuropathy (CAN), (6). Intriguingly, patients with diabetes experience a parasympathetic denervation, with an early augmentation of sympathetic tone, then leading to impaired heart rate variability, resting tachycardia, exercise intolerance, abnormal blood pressure regulation, and orthostatic hypotension (7). In addition, in T2DM there is a compensatory increase in the cardiac sympathetic tone in response to subclinical peripheral denervation (7). However, the T2DM may be seen as a relevant risk factor and a trigger to alter the autonomic system balance, and to cause vaso vagal syncope. Actually, the association between diabetes and autonomic dysfunction and the vaso vagal syncope recurrence at follow up is not well established. Moreover, the recent studies cannot come to definitive conclusion about the diabetes as risk factor and/or as trigger of vaso vagal syncope events, and about its implication to cause future recurrences in affected patients. Conversely, heart rate variability (HRV) is a simple, reproducible and well-recognized method for evaluating sympatho vagal activity (8, 9). However, in this study authors evaluated the autonomic dysfunction as alteration in HRV, and its relevance to cause vaso vagal syncope, and the vaso vagal syncope recurrence in diabetics vs. non diabetics at 12 months of follow up.

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Study Type : Observational
Actual Enrollment : 242 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Cardiac Autonomic Dysfunction is Predictive of Vasodepressor and Mixed Vaso Vagal Syncope Recurrence in a Propensity Score Matched Analysis of Type 2 Diabetics vs. Non Diabetics Patients Without Organic Heart Disease.
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : February 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
type 2 diabetes mellitus (T2DM) patients
T2DM patients affected by vaso vagal syncope. All these patients received before to perform and Head upTilt test and ecg Holter monitoring.
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.

patients without T2DM
Patients without T2DM affected by vaso vagal syncope. All these patients received before to perform and Head upTilt test and ecg Holter monitoring.
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.




Primary Outcome Measures :
  1. syncope recurrence [ Time Frame: 12 months. ]
    authors will report all syncope recurrences at 12 months of follow up in T2DM patients vs. non T2DM patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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%).
Criteria

Inclusion Criteria:

  • patients with diagnosis of vaso vagal syncope, and left ventricle ejection fraction >55%.

Exclusion Criteria:

  • patients with neuropathy, arterial hypertension, indications of heart failure and coronary heart disease or depression of left ventricle ejection fraction (LVEF < 55%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717207


Locations
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Italy
Raffaele Marfella
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

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Responsible Party: Celestino Sardu, medical doctor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03717207    
Other Study ID Numbers: 2210012018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syncope
Autonomic Nervous System Diseases
Primary Dysautonomias
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance