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Syncope clinical trials

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NCT ID: NCT05776810 Not yet recruiting - Syncope Clinical Trials

Syncope Trial to Understand Tilt Testing or ECG Recording Tenth Prevention of Syncope Trial

(POST10)
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The Study To Understand Tilt Tests versus Extended Recordings (STUTTER, POST 10) will test the hypothesis that first performing a diagnostic HUT in older patients with syncope of unknown cause will provide earlier and more diagnoses than inserting an ICM.

NCT ID: NCT05755737 Recruiting - Syncope Clinical Trials

A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)

POST 11
Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial.

NCT ID: NCT05752682 Recruiting - Fall Clinical Trials

Global Approach to Faint and Falls

F2
Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

Syncope is the most frequent cause of transient loss of consciousness. Falls are very common in older people. If the falls are unexplained and not accidental, it is likely that the patient had a syncope event and showed a lack of awareness for loss of consciousness. The management of unexplained falls is the same as that of syncope. There is a gap between the best available scientific evidence provided by the guidelines and the need to disseminate these concepts in clinical practice. The absence of a systematic comprehensive approach to fainting and falls results in higher health and social costs, unnecessary hospitalizations and diagnostic procedures, prolonged hospital stays, lower diagnostic rates, and higher rates of misdiagnosis and symptomatic recurrence. Aim of the study The aim of the study is to assess the efficacy (adherence) of a diagnostic protocol and the costs of a comprehensive guideline-based approach to the management of fainting and falls in a population of consecutive patients referred to a dedicated multidisciplinary outpatient facility. Primary endpoint: 1. Prevalence rate of patients with unexplained fall undergoing diagnostic investigations for syncope among those initially subjected to a diagnostic evaluation for falls. Secondary endpoints: 1. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of diagnostic tests and final diagnosis. 2. Comparison between patients initially assigned to syncope and those assigned to unexplained fall in terms of adherence to guideline recommendations. 3. Analysis of costs per patient of fall and syncope protocols 4. All previous analyses will be performed according to the following age groups: ≥75, 74-65 and 64-40 years. Inclusion criteria 1. Consecutive patients >40 years of age, belonging to the Cwithin Fainting and Falls for the evaluation of an episode of syncope or fall. 2. Fragile patients at risk of falling. Exclusion criteria: 1. Patients aged <40 years 2. Patients with dental falls 3. Patients with a known diagnosis of syncope 4. Patients in whom syncope and fall are secondary symptoms of severe underlying comorbidities

NCT ID: NCT05751330 Recruiting - Clinical trials for Neurally Mediated Syncope

Italian Cardioneuroablation Study for Neurocardiogenic Syncope Patients

ItalianCNA
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Multicenter Italian interventional "proof of efficacy" clinical trial that aims to evaluate the incidence of asystolic pauses and heart rate in patients with CNS who performed severe CNA identified through asystolic pauses identification by implantable loop recorder. The study is independent, "investigator-initiated," sponsored by a nonprofit scientific association called the Italian Multidisciplinary Group for the Study of Syncope (GIMSI).

NCT ID: NCT05729724 Completed - Syncope Clinical Trials

Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)

SynABPM
Start date: October 5, 2022
Phase:
Study type: Observational [Patient Registry]

SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure

NCT ID: NCT05728255 Not yet recruiting - Syncope Clinical Trials

Assessment of the Mechanism of Non-cardiac Syncope

2STEPS
Start date: April 2024
Phase:
Study type: Observational

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

NCT ID: NCT05708963 Completed - Clinical trials for Cardiovascular Diseases

The U.K. Embryologist Fatigue Study

FUSE-UK
Start date: January 16, 2023
Phase:
Study type: Observational

The purpose of the study is to determine physical and mental health issues of U.K. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

NCT ID: NCT05695755 Recruiting - Clinical trials for POTS - Postural Orthostatic Tachycardia Syndrome

Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency

Start date: November 1, 2022
Phase:
Study type: Observational

The present study aims to: 1. Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023 2. Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.

NCT ID: NCT05657925 Not yet recruiting - Sleep Syncope Clinical Trials

Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)

POST9
Start date: December 1, 2024
Phase: Phase 3
Study type: Interventional

At least 5% of patients with vasovagal syncope also have Sleep Syncope. Patients awake from sleep with profound malaise and gastrointestinal vagal symptoms. About 75% have severe nausea and about 40% have lower abdominal cramps. Some faint while supine, but most find their symptoms so severe that they rise quickly and hurry to the bathroom. Sometime either on the way to the toilet, near it, or shortly afterwards they faint. The nausea is followed by vomiting, and the cramps by watery diarrhea. After relief the patients remain presyncopal, diaphoretic, and tired. Almost all patients also have clinical vasovagal syncope during daytime hours. The cause of this is unknown. Orthostatic stress cannot be a factor in triggering the event, and in isolated case reports it occurs during non-REM sleep. There is no classic provocative situation of pain, the sight of trauma, or the presence of medical settings. These suggest the importance of central processes and the reduced likelihood that strategies that target maintaining preload (such as with midodrine and fludrocortisone) would be helpful. As well, midodrine is avoided during the night. Recently the investigators reasoned that if the investigators could rapidly suppress the nausea patients could remain supine, wait out the nausea, and not faint with orthostatic stress. Ondansetron is a potent anti-nausea medication that has rapidly dissolving preparations. Nine patients were instructed to keep one at the bedside, insert it upon waking up with nausea, remain in bed, and raise their legs (if possible). There was partial success with ondansetron 4 mg and complete success with ondansetron 8 mg. This remarkable but anecdotal observation requires formal testing. Research Objectives: the investigators will test the hypothesis that ondansetron 8 mg prn sublingually on awakening with moderate to severe nausea prevents loss of consciousness in patients with prior Sleep Syncope who awaken with malaise and nausea. Study Design & Methodology: The main study will be a placebo-controlled, double-blind, randomized, crossover clinical trial. The primary outcome will be the progression of awakening with nausea to syncope. Thirty patients with Sleep Syncope will be randomized 1:1 to receive packages of either ondansetron 8 mg sublingual tablets or matching placebo. They will each receive 3 boxes of 10 tabs, with refills available if needed. Each crossover period will last 6 months. In a substudy the investigators will test whether the predominant disturbed physiology is bradycardia, decreased venous return, or decreased systemic vascular resistance. This will be assessed using a unique, small, wearable blood pressure sensor that can be rapidly donned on the ear. It records heart rate and beat-to-beat waveforms, which permit estimating stroke volume, systemic vascular resistance, and cardiac output. the investigators will record these variables in all patients continuously from when the device is put on until 30 minutes afterwards. the investigators hypothesize that unlike during syncope provoked by head-up tilt testing, here there will be no decrease in preload until patients arise, and that the main physiologic disturbance during syncope is hypotension due to decreased preload superimposed on heart rate collapse. Anticipated Outcomes: If successful, this research would be i) the first to report a well-tolerated and highly effective treatment for most sleep syncope, and ii) the first to report the physiology of brain-initiated vasovagal syncope in the community outside a laboratory environment.

NCT ID: NCT05649891 Not yet recruiting - Pneumonia Clinical Trials

Checklists Resuscitation Emergency Department

Start date: September 2023
Phase: N/A
Study type: Interventional

The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.