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Syncope, Vasovagal clinical trials

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NCT ID: NCT03835299 Completed - Blood Donors Clinical Trials

Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.

NCT ID: NCT03717207 Completed - Syncope, Vasovagal Clinical Trials

Cardiac Autonomic Dysfunction in Diabetics Patients With Syncope

Start date: January 1, 2010
Phase:
Study type: Observational

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.

NCT ID: NCT03533829 Completed - Syncope, Vasovagal Clinical Trials

Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study

Start date: June 4, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.

NCT ID: NCT02954666 Completed - Cardiac Disease Clinical Trials

Second Study on Cardio-neuromodulation in Humans

CardNMH2
Start date: December 10, 2016
Phase: N/A
Study type: Interventional

Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more limited and specific approach of CNA, called cardio-neuromodulation (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an innovative anatomic strategy. The feasibility of CardNM has already been tested in our center in a limited first study in humans (CardNMH1), with a favorable outcome for the patients involved. The results of CardNMH1 have been submitted for publication. The purpose of this second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data in well-defined patient groups.

NCT ID: NCT02949804 Completed - Vasovagal Syncope Clinical Trials

Relation Between Vasovagal Tendency and Smoking Among University Students

Start date: December 2016
Phase: N/A
Study type: Observational

Almost everyone is aware these days is aware about the risk of smoking. Still many people start this habit specially in early life and during college year. We aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness, smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation between smoking and a positive tilt table test which is indicative of vasovagal tendency. By collecting the information regarding smoking habit and vasovagal symptoms analysis can be done to see if there is correlation between these two factors

NCT ID: NCT02874937 Completed - Syncope, Vasovagal Clinical Trials

A Proof of Principal Study of Atomoxetine for the Prevention of Vasovagal Syncope

POST6
Start date: February 2015
Phase: Phase 2
Study type: Interventional

Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and probably is responsible for CDN $250 million in health care spending each year.There is no known medical treatment for frequent fainting. Two randomized studies suggest that inhibition of norepinephrine transport (NET) reuptake with sibutramine and reboxetine (NET inhibitors) prevents syncope on tilt testing by about 80%, and the investigators reported that sibutramine markedly reduced the frequency of vasovagal syncope in 7 of our most symptomatic patients. Sibutramine and reboxetine, for different reasons, are not available in Canada. However atomoxetine is available and is used to help patients with attention deficit disorder. There are no data pertaining to its hemodynamic effects in patients with vasovagal syncope. Although a randomized clinical trial of atomoxetine for the prevention of vasovagal syncope would be needed before clinical use, the investigators first need a proof of principle study. The objective is to determine in a prospective, randomized, parallel, double-blind study if atomoxetine 40 mg bid in patients at least 18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.

NCT ID: NCT02726776 Completed - Clinical trials for Orthostatic Hypotension

Suspension Syndrome

Start date: September 2015
Phase: N/A
Study type: Interventional

Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.

NCT ID: NCT02636712 Completed - Vasovagal Syncope Clinical Trials

Observation of ImageReady™ MR Conditional Pacing System in China

Start date: December 8, 2015
Phase:
Study type: Observational

To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects

NCT ID: NCT02573649 Completed - Clinical trials for Syncope, Vasovagal, Neurally-Mediated

The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

TIRECS
Start date: April 2015
Phase: N/A
Study type: Interventional

Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

NCT ID: NCT02500732 Completed - Vasovagal Syncope Clinical Trials

Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope

POST6
Start date: July 2015
Phase: Phase 2
Study type: Interventional

Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.