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Syncope clinical trials

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NCT ID: NCT05887323 Active, not recruiting - Heart Failure Clinical Trials

LBBAP Data Collection Registry

Start date: April 25, 2023
Phase:
Study type: Observational

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

NCT ID: NCT04790058 Active, not recruiting - Syncope Clinical Trials

CSRS Implementation - A Pilot Study

Start date: August 20, 2021
Phase:
Study type: Observational

Syncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and the high costs. Our group has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS based practice recommendations to demonstrate its real-world effectiveness. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.

NCT ID: NCT04229589 Active, not recruiting - Syncope Clinical Trials

Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

SYNCOPACED
Start date: January 1, 2010
Phase:
Study type: Observational [Patient Registry]

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

NCT ID: NCT03970551 Active, not recruiting - Syncope Clinical Trials

Lower Body Muscle Pre-activation in Initial Orthostatic Hypotension

IOH
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This study is aimed primarily at providing a simple and effective form of treatment to reduce the symptoms of Initial Orthostatic Hypotension (IOH) and prevent syncope. We will first characterize the physiology of IOH, and then we will study four sit-to-stand maneuvers, each with a different stress tests to identify the role of sympathetic activity vs. simple muscle contraction in IOH. Then we will complete an additional two sit-to-stands with interventions designed to decrease the blood pressure drop (and hopefully symptoms) with initial stand. These consist of physical counter maneuvers, which may be a possible treatment that can be used to mitigate the drop in blood pressure (BP) seen in IOH during a stand and relieve presyncope symptoms.

NCT ID: NCT03940066 Active, not recruiting - Atrial Fibrillation Clinical Trials

Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile

Monitor- ACS
Start date: November 12, 2019
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the efficacy of monitoring after discharge of patients with high-risk acute coronary syndrome.

NCT ID: NCT03231449 Active, not recruiting - Stroke Clinical Trials

A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

FEVRIER
Start date: February 1, 2017
Phase:
Study type: Observational

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

NCT ID: NCT02854683 Active, not recruiting - Clinical trials for Chronic Fatigue Syndrome

Reducing Orthostatic Intolerance With Oral Rehydration in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients

Start date: February 2016
Phase: Phase 1
Study type: Interventional

We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate prolonged standing. OI in ME/CFS is often accompanied by either postural tachycardia syndrome (POTS) in which standing results in an excessive heart rate, and neurally mediated hypotension (NMH) in which standing causes a fall in blood pressure and fainting. Intravenous fluids can alleviate these symptoms, but is difficult to administer; oral fluids fail to provide the same benefit. We would therefore like to test the effectiveness of an oral rehydration solution (ORS, W.H.O. formula) making use of co-transport of glucose and sodium, to reverse these symptoms in ME/CFS subjects with POTS or NMS, and will compare these results with healthy control subjects.

NCT ID: NCT02558972 Active, not recruiting - Clinical trials for Postural Tachycardia Syndrome (POTS)

Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of consciousness and represents the acute episodic form of orthostatic intolerance (OI). Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by debilitating symptoms and signs while upright relieved by recumbency. Northera should therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the orthostatic response in POTS and VVS.

NCT ID: NCT02123056 Active, not recruiting - Vasovagal Syncope Clinical Trials

Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects

Start date: October 2014
Phase: Phase 4
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. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. The most common cause is vasovagal syncope. This occurs in people of all ages, and is a lifelong predilection. While the median number of faints in the population is 2, those who come to the investigators care have a median 10-15 lifetime spells, and have an increased frequency in the year before presentation. Vasovagal syncope is due to abrupt hypotension and transient bradycardia, which cause cerebral hypoperfusion. The pathophysiology may be either failure of venous return or progressive vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic stimulation might be involved early in the reflex cascade. There is no known medical treatment for frequent fainting. The investigators performed the pivotal CIHR-funded randomized trials that showed that neither permanent pacing, beta blockers, nor fludrocortisone help the majority of patients. However 3 observational studies suggested that beta blockers prevent syncope in older subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, -stratified analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis showed a benefit from metoprolol in these patients, with a hazard ratio of 0.52 (CI 0.27 to 1.01), and an age-specific response to beta blockers (p = 0.007). These results suggest the need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope in older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92% agreed to participate in such a trial. Separately, this study emerged as the first choice for syncope randomized trials after consultation with Canadian and international experts. Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate to severely frequent vasovagal syncope will better suppress syncope recurrences than placebo. Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled, randomized clinical trial. Patients will be enrolled during a recruitment period of 4 years and followed for a fixed period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of vasovagal syncope based on a quantitative diagnostic score. They will be randomized to receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will be made according to treating physician discretion to optimize tolerance and compliance while maximizing dose. The primary outcome measure will be the time to the first recurrence of syncope (after a 2 week dose titration wash-in period) over the 1-year observation period. The primary analysis will be performed on an intention-to-treat basis. Secondary analyses will include an on-treatment analysis, as well as analyses comparing syncope and presyncope frequency, number needed to treat, quality of life, impact of syncope on daily living, and cost from the perspective of the publicly funded health care system. The investigators will enroll 248 patients to have an 85% power to detect a reduction (p<0.05) in the primary outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative risk reduction. This sample size also allows for a 11% rate of subject dropout with loss to follow-up before a syncopal event. The University of Calgary Syncope Clinic has a well-functioning clinical trial apparatus that successfully completed the randomized, multicenter Prevention of Syncope Trials (POST1: metoprolol for vasovagal syncope; POST2: fludrocortisone for vasovagal syncope) and SIRCAT (Statin-Induced Reduction of Cardiomyopathy Trial). Enrolment is underway in the CIHR-funded POST3 (pacing versus loop recorders in syncope patients with bifascicular block) and POST4 (midodrine for vasovagal syncope). Study centres that were highly productive in POST1-4 have agreed to participate. The investigators therefore will have ample syncope enrolling centres. Relevance: This study will provide evidence to inform the use of metoprolol in the treatment of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the lack of any other conventional medical therapy the investigators expect it to have rapid impact on care.

NCT ID: NCT01965899 Active, not recruiting - Syncope Clinical Trials

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor