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NCT ID: NCT04581252 Not yet recruiting - Heart Failure Clinical Trials

Heart Failure HemOdynamic Prognostic Evaluation and OutcomE (HF-HOPE) Study

HF-HOPE
Start date: November 1, 2020
Phase:
Study type: Observational

Summary of the HF-HOPE study: Background and existing knowledge gap: As per the Canadian Chronic Disease Surveillance System, about 1 in 12 Canadian adults aged ≥20 live with diagnosed heart disease. Every hour, about 12 Canadian adults aged ≥20 die due to heart failure (HF). It is estimated that HF results in direct costs of more than $2.8 billion per year in Canada alone. As per the Canadian Society of Cardiology, heart failure is defined as "a complex clinical syndrome in which abnormal heart function results in, or increases the subsequent risk of, clinical symptoms and signs of reduced cardiac output and/or pulmonary or systemic congestion at rest or with stress". Although HF is defined as "reduced cardiac output state" no objective parameters are set to define the condition. Invasive monitoring is routinely used in hemodynamic evaluation of critically ill patients admitted in the hospital, however, there is no reliable tool available to measure hemodynamic parameters that may predict, immediate or long-term, risk of worst health outcomes in stable HF patients. We hypothesize that non-invasive bioimpedance-based hemodynamic parameters can be used as a predictive tool for health outcomes in patients with HF. To ascertain this, we propose the first of its kind HF-HOPE study. Objectives of HF-HOPE study are to 1) characterize hemodynamic measures of resting versus post-exercise (mounted ergometer) in patients with all-comer stable HF subjects, irrespective of their HF etiology using Non-Invasive Cardiac System (NICaS); 2) correlate NICaS-derived hemodynamic parameters to identify, early- and long-term risk of worse health outcomes (unplanned hospital admission due to HF or arrhythmias; listing for heart transplantation/palliative care; and death); 3) correlate the lean body mass (muscle and skeleton) with their body mass index (kg/m2) and the risk of worse health outcomes; and 4) Nested cohort study: identify the outcome-associated biomarkers of chronic HF by employing a non-targeted metabolomics/lipidomics approach. Methods: The HF-HOPE is a single center, prospective, double-blind, pragmatic clinical study. It will be conducted at St. Boniface general hospital, Manitoba's tertiary cardiac center. Patients aged ≥18 years, irrespective of any sex or gender, with confirmed diagnosis of HF will be enrolled in the study. Hemodynamic measurements (stroke volume, cardiac output, cardiac index, total peripheral vascular resistance, and cardiac power index) will be assessed using NICaS at 3-times (at rest in supine, siting position as well as after exercise on a mounted ergometer) at baseline and 6 months (±1 month) in each enrolled participant. Patients will be followed to record health outcomes as outlined above, each year. The BodPod, air displacement plathysmography device will be used to determine body compositions at baseline and 6-month. Baseline demographic data will be gathered. To optimize the use of clinical resources, we will collect blood and urine samples for non-selective metabolomics and lipidomics profiling by adopting -omics approach as a nested cohort study. Statistical analysis: Assuming the 8 to 12% 1-year mortality rate following admission with HF, a projected sample size of 500 would be suffice. Conservatively 4 covariates will be included in multivariable statistical models, while testing the independent effect of the relevant NICaS parameters of interest. We will perform subgroup analysis using age, sex, ethnicity, concomitant disease conditions, medications, and lean body mass. Anticipated outcomes and future implications: The HF-HOPE study is the first of its kind study employing non-invasive hemodynamic parameters to predict worsening health outcomes over time in HF patients. The successful outcomes will provide a promising cost effective, rapid, and reliable tool to predict worsening health outcomes before it actually lead to hospitalization, tissue damage or death. This early warnings will provide adequate time for appropriate intervention. The HF- HOPE study has been meticulously designed to replicate the pragmatic conditions while assessing the non-invasive hemodynamic measurements to widen the knowledge translation of outcomes to change the clinical practice of HF patient management. Further, this may provide supporting data for future randomized trial to replace the costly, resource-intense, and complex invasive tool to determine hemodynamic measurements in HF patients.

NCT ID: NCT04576026 Not yet recruiting - Ketosis Clinical Trials

Exogenous Ketone Supplementation and Cognitive Function During Exercise

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue

NCT ID: NCT04562142 Not yet recruiting - Clinical trials for Coronary Artery Disease

A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study

Start date: March 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.

NCT ID: NCT04551274 Not yet recruiting - Mood Clinical Trials

Music Therapy in Frontline Healthcare Workers

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The objective of this project is to investigate the impacts of the COVID-19 pandemic on frontline healthcare workers, and determine if a virtual music therapy can improve mood and emotional state in this population. For this pilot study, EEG will also be used to assess measures of functional connectivity, attention, and mood in adult participants. Participants will also be evaluated for measures of emotion using a standardized test battery (NIH toolbox). This pilot study will show how frontline healthcare workers have been impacted by the COVID-19 pandemic, and provide evidence as to the effectiveness of Music Therapy to support mental health in this essential population.

NCT ID: NCT04540640 Not yet recruiting - Clinical trials for Kidney Transplantation

Oxygenated Machine Preservation in Kidney Transplantation

SNOPO
Start date: September 2020
Phase: N/A
Study type: Interventional

Kidney transplantation remains the best treatment option for patients with end-stage kidney failure, however, the need for transplantable organs far exceeds the number of acceptable grafts available from deceased donors. In an effort to increase access to transplantation, organs from higher risk donors are being used more frequently. Patients who receive these high risk kidneys are more likely to experience poor outcomes post-transplantation, such as delayed graft function and shorter graft survival than those who receive standard criteria donor kidneys. One way to improve outcomes in these high risk kidneys is to limit the amount of damage donor organs sustain during the transplant process. The current standard of care is storage of the donor organ on ice until the time of transplant, during which the kidney incurs injury from cold and lack of oxygen. Recent research suggests that oxygenated machine perfusion of the organ at room temperature as a storage method can help protect kidneys and improve post-transplant outcomes. This study aims to assess the feasibility and safety of room temperature oxygenated machine perfusion of donor kidneys prior to transplantation. Kidney function will be evaluated with standard clinical parameters and participants will be followed for one-year post-transplantation for their outcomes. Feasibility will be evaluated in terms of trial process such as recruitment rate and ease of implementation of the study intervention. Preliminary safety will be assessed by incidence of graft discard and technical limitations.

NCT ID: NCT04537611 Not yet recruiting - Stroke Clinical Trials

Deoxyhemoglobin Concentration Changes and Cerebral Perfusion Imaging

Start date: August 2021
Phase: N/A
Study type: Interventional

To investigate a new method to rapidly modulate pulmonary venous hemoglobin oxygen saturation to enable the use of deoxyhemoglobin concentration in arterial blood as an intra-arterial MRI contrast agent for cerebral tissue perfusion imaging.

NCT ID: NCT04532190 Not yet recruiting - Clinical trials for Attention-Deficit/Hyperactivity Disorder (ADHD)

Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder

FAST-ADHD
Start date: August 31, 2022
Phase: N/A
Study type: Interventional

Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. Here, we will test if repetitive transcranial magnetic stimulation (rTMS) can reduce the symptoms of ADHD.

NCT ID: NCT04530058 Not yet recruiting - Burns Clinical Trials

The Effects of Metformin on Morbidity and Mortality in Elderly Patients

MET-ELD
Start date: March 2024
Phase: Phase 2
Study type: Interventional

Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.

NCT ID: NCT04495959 Not yet recruiting - Prostatic Cancer Clinical Trials

Dynamic Whole Body PET/ MRI

Start date: August 2024
Phase:
Study type: Observational

Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return.Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use 68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.

NCT ID: NCT04493944 Not yet recruiting - Self Efficacy Clinical Trials

Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance

(CuisiAlg)
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Seaweeds have been part of the diet of Asian countries for thousands of years, but consumption by Quebecers remains unfamiliar. Because of their rich nutrients content and unique bioactive compounds, seaweeds have a great dietary potential. The overall objective of the project is to determine the potential for sustainable local exploitation of St. Lawrence seaweeds by assessing their quality under growing conditions and following processing, and to use them as a basis for culinary innovations for both industry and consumers. Our specific objectives are as follows: 1. To assess the impact of environmental factors on the specific profile of biomarkers of nutritional quality and health potential of harvested or cultivated seaweed; 2. To determine the impact of processing on the profile of biomarkers of nutritional quality and health potential of harvested and cultivated seaweed; 3. To study changes in dietary attitudes and behaviours through a culinary workshop promoting the acceptance of seaweeds and their appropriation as an ingredient by consumers. The application for ethical approval and this trial registration applies only to Specific Objective 3.