Filter Results

Clinical Studies

Open

Contact Us for the Latest Status

Closed for Enrollment

  • A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF) Scottsdale/Phoenix, Ariz.

    The purpose of this 12 week study is to assess the safety of oral IW-1973 when administered to patients with heart failure with preserved ejection fraction (HFpEF) and its effect on peak exercise capacity, both in all patients and in patients without permanent or persistent atrial fibrillation

  • A Novel Algorithm to Estimate Critical Power within a Single Visit to the Laboratory Rochester, Minn.

    The purpose of this study is to develop a novel algorithm that will estimate critical power (CP) from a modified incremental exercise protocol that does not require highly supramaximal cycling efforts. This exercise protocol will be compared to the CP determined by the “gold-standard” traditional testing method described below.

  • Age-Dependent Changes in Echocardiographic Measures of Pulmonary Vascular Distensibility and Effects on Lung Diffusing Capacity Rochester, Minn.

    The purpose of this study is to determine if the change in pulmonary vascular compliance with positional changes (upright, supine, and Trendelenburg position) is different in younger versus older individuals.

  • Alterations of Pulmonary Vascular System in Patients Supported By Continuous Flow Left Ventricle Assist Device (LVAD) Rochester, Minn.

    The purpose of this study is to assess the impact of continuous-flow Left Ventricle Assist Device (LVAD) therapy and total artificial heart  (TAH) therapy on the alveolar-capillary interface and bronchial circulation of lungs in patients with heart failure (HF).

  • Alveolar-Capillary Recruitment as a Screening and Tracking Tool for Patients with Pulmonary Arterial Hypertension Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine if non-invasive measurement of blood flow to the lungs and the movement of gas from the lungs to the blood stream at rest and in response to low to moderate intensity exercise can be used as an assessment tool to allow for earlier detection and monitoring of individuals with pulmonary-arterial hypertension, and the response to drug treatments.

  • An Open Label Study of GBT440 to Evaluate the Effect on Oxygenation in Healthy Subjects at Rest and Maximal Exercise under Hypoxic Conditions Rochester, Minn.

    The purpose of this study is to evaluate the effects of GBT440 on the body and oxygen saturation levels , assessed at rest and at maximum exercise under conditions of low oxygen in the atmosphere.

  • Cardiopulmonary Exercise Heart Sound S1 (CPXS1) (CPXS1) Rochester, Minn.

    The purpose of this study is to evaluate the ability to determine the first heart sound (S1) and its relationship to aerobic capacity.

  • Cerebral Blood Flow Regulation and Cognitive Function in Adults with Cardiovascular Disease - Influence of Exercise Training and Intensity (CR-CBF) Rochester, Minn.

    Dementia is a disease that causes a person to lose their memory, speech, and thinking skills. People with heart disease are at high risk of brain function decline, that can lead to dementia. Reduced blood flow to the brain can cause this decline in brain function. Factors linked with heart disease (such as poor blood vessel function and low fitness level) also lead to reduced brain blood flow. Exercise training can improve these factors. However, it is unknown what type of training is best for improving brain blood flow and function.

    High intensity interval training (HIIT) is a type of training where bouts at a hard effort (cannot talk while breathing), alternate with bouts at a low effort. Moderate intensity training (MICT) is a type of training at a medium effort (can talk while breathing) that can usually be done without stopping. In people with heart disease, HIIT has been shown to double fitness and blood vessel function compared to MICT. As a result, we believe that HIIT will be better than MICT for increasing brain blood flow and brain function in these patients. To answer this, we will study people with heart disease after a heart event and use specialized tests to measure their brain blood flow and function. We will randomly assign patients to HIIT or MICT during a heart rehab program. Some patients also choose not to participate in the heart rehab program. After 12 weeks we will repeat the tests, to see whether exercise training improves brain blood flow and function, and whether HIIT or MICT lead to greater improvements. We will also study people without heart disease to assess what level of brain blood flow and function is normal for their age, to compare against our patients. We will also assess other factors about our patients that could help identify a low level of brain blood flow or function.

    There are 47 million people in the world that have dementia. About 30% of these cases are linked to heart disease. This study will help us better understand brain blood flow and brain function in people with heart disease. It will help assess the amount of impairment caused by a heart event and heart disease. This study will also help identify types of patients, that are more likely to have low levels of brain blood flow and function. This could lead to a risk calculator for doctors, to identify patients that need additional tests or monitoring. The study will also determine if exercise during a heart rehab program can improve brain blood flow and function, and whether HIIT or MICT is better. This could allow for a targeted program to improve or maintain brain health; and reduce the risk of dementia.

     

  • Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (ADI) Rochester, Minn.

    The purpose of this study is to evaluate whether or not the ADI CPM Monitoring System will be able to measure respiration rate and relative changes in tidal volume in healthy human volunteers with enough accuracy and precision to validate the intended use of the system, and thoracic impedance with enough precision and consistency with respect to reference measurements to validate the intended use of the system.

  • Data Collection - Atrial Fibrillation Exploratory Study - CAFE (CAFE) Rochester, Minn.

    The purpose of this study is to characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable Insertable Cardiac Monitor (ICM) prototype device.

  • Determinants of Pulmonary Congestion in Heart Failure Rochester, Minn.

    The purpose of this study is to measure and identify chest fluid volumes associated with heart failure and to determine their impact on lung structure and function, and also assess the effect of body position on shifts in fluid and the effects of this on lung function, mechanics and gas exchange.

  • Determination of Changes in Lung Diffusing Capacity, Cardiac Output, and Pulmonary Vascular Pressures During Exercise in Younger versus Older Individuals Rochester, Minn.

    The purpose of this study is to determine and compare changes in lung diffusing capacity, cardiac output, and pulmonary vascular pressures during exercise for younger versus older individuals. It is possible that the blood vessels of the lungs play a greater role in unexplained exercise intolerance and shortnesss of breath in older individuals than previously thought.

  • Gene Polymorphisms in Cardiovascular Health and Disease Rochester, Minn.

    The purpose of this study is because we are testing the variation in a gene that may influence receptors in your heart, blood vessels and lungs.

  • Heart Sounds Measurement Using The Wearable Cardioverter Defibrillator In Hospitalized Acute Heart Failure Patients (HEARIT-AHF) (HEARIT-AHF) Scottsdale/Phoenix, Ariz.

    A study to evaluate the changes in heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) during the medical treatment of hospitalized acute heart failure (AHF) patients.

  • HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia Rochester, Minn., Scottsdale/Phoenix, Ariz.

    A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program.

    To validate the diagnostic performance of the HeartTrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using EST.

    Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis by the HeartTrends device for the detection of myocardial ischemia, as determined by stress echocardiography.

  • Hospital Admission in Heart Failure: Readiness for Discharge and Predicting Future Admissions Rochester, Minn.

    The purpose of this study is to identify measures of heart rate and heart rate variability responses to changes in nervous system activity, breathing variability, and lung fluid in HF patients as early as possible in the course of their hospital admission and subsequently just prior to discharge, using a simplified approach, in order to determine if these measures can assess readiness for discharge and more accurately predict likelihood for readmission.

  • Longitudinal Lung Health Study Scottsdale/Phoenix, Ariz., Rochester, Minn.

    The purpose of this study is to investigate the impact of environment, lifestyle, and genetics on lung health. This will be investigated through a collaboration with the Wortman Lung Cancer Foundation and ongoing 5 and 10 K races associated with the Foundation. The early phases of the study will focus primarily on a web based approach to data collection but additional measures will be added.

  • Mayo Clinic DAHLC–CTSA (CRU)–Aging Center: Cross Sectional Study on Healthy Aging Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The aim is to look at the changes to the body’s heart, lung and muscular systems due to aging and to better predict these changes using wireless devices and assess the ability to accurately monitor these changes.

  • Mayo Clinic Pilot Studies towards Optimizing Quality of Life and Outcomes in VAD Patients Rochester, Minn.

    The purpose of this study is to use a simplified lung assessment which could offer patients a novel, convenient and non-invasive evaluation of the actual status of the heart and lung interaction with the LVAD (Left Ventricular Assist Device).

  • Multimodal and Multiparameter Home Monitoring of Post-Discharge Congestive Heart Failure Patients: Pilot Study for Early Data Gathering Rochester, Minn.

    The primary purpose of this study is to collect long-term (2-month duration) data with the ADI CHF Device on patients at home to demonstrate effectiveness of the device in accurately measuring biologically relevant parameters and detecting fluid status as compared to the standard of care (weight scale).

  • Non-invasive Fluid Volume During Fluid Shifts Technique Validation Rochester, Minn.

    This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume. It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.

  • Noninvasive Lung Fluid Determination using the uCor System and Comparison to Computed Tomography Lung Fluid Readings (PATCH-CT) (PATCH-CT) Rochester, Minn.

    The purpose of this study is to:

    1. Compare computer tomography (CT) determined lung fluid content with µCor Systems's thoracic fluid readings in patients with and without evidence of heart failure (HF).
    2. Observe the effect of location of the µCor System on the thoracic fluid readings.
  • Pilot Study on Pulmonary Mechanics of Playing Wind Instruments Rochester, Minn.

    The purpose of this pilot study is to examine lung function of long time harmonica players and understand the pulmonary mechanics of harmonica playing including the abdominal and thoracic pressures generated and the pattern of muscle activation.

  • Pulse Oximetry During Heart Failure Exercise Stress-Test Evaluations Rochester, Minn.

    The purpose of this study is to compare pulse oximetry performances from different manufacturers and with different anatomical sensor locations during stress tests in heart failure patients, evaluating effectiveness against motion and poor circulation.

  • Quantification of Pulmonary Vascular Stiffness and Protein Expression in Human Lungs with Aging Rochester, Minn.

    The purpose of this study is to assess the effect of aging on the blood vessels of the lungs by focusing on the proteins involved in contraction of smooth muscle cells.

  • Recording Breath Acoustics and Lung Mechanics in Patients with COPD, Asthma, and Cystic Fibrosis Scottsdale/Phoenix, Ariz.

    The purpose of this study is to obtain breath acoustic recordings and measures of lung mechanics in patients with COPD, asthma, and cystic fibrosis breathing at rest and during light submaximal exercise. The plan is to examine these respiratory acoustics and mechanics in relation to determinants of disease and/or disease states (classic respiratory pathophysiology) and quality of life measures in these patient populations to determine if any relationship or patterns exist when comparing across respiratory diseases and within a condition based on disease severity.       

  • Respiratory Causes Impacting Pilot Performance Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to complete a series of three distinct tasks to address respiratory causes impacting pilot performance.

    Task 1, entitled "Variable Oxygen Concentration Study," is to evaluate the three exposure variables through three study aims - differing on the oscillation frequency time windows or amplitude of the oxygen/nitrogen fluctuations.

    The purpose of Task 2, entitled "The Cognitive Performance Cost of Increased Work of Breathing: Phase II," is to determine the impact of inspiratory and expiratory pressure-threshold loading on cognitive performance.

    The purpose of Task 3, entitled "Causes of Decrements in Lung Physiology in High Performance Flight Operations," will be to understand the influence of various respiratory loads on development of decrements in lung physiology.

  • Sleep Quality and Microclimate Study Rochester, Minn.

    Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

  • Smart Fabric for Cardio-Performance Enhancement Based on Human Spacesuit Design Rochester, Minn.

    The aims of this study are to develop a smart fabric untethered compression garment to dynamically oppose orthostatic changes and that can be synchronized to position change or an individual’s electrocardiogram. We also aim to determine the compression thresholds needed, timing and synchrony of compression for human applications. Furthermore, we will demonstrate maintenance of blood pressure and reduced autonomic responses to tilt table testing or LBNP (lower body negative pressure) and evidence of augmented venous return by synchronizing compression during diastole.

  • Studies on the Health Benefits of Pulsed Electromagnetic Field Therapy using Bioboosti Scottsdale/Phoenix, Ariz.

    The purpose of this study is to observe the effects of treatment from a device called the Bioboosti which utilizes pulsed electromagnetic waves on blood vessel function and blood pressure.

  • Studies on the Health Benefits of Pulsed Electromagnetic Field Therapy using Bioboosti Scottsdale/Phoenix, Ariz.

    While the potential clinical uses of pulsed electromagnetic field therapy (PEMF) are extensive, we are focusing on the potential benefits of PEMF on vascular health. We are targeting, the pre diabetic - metabolic syndrome population, a group with high prevalence in the American population. This population tends to be overweight, low fitness, high blood pressure, high triglycerides and borderline high blood glucose.

  • Studies using Doubly Labeled Water in Measuring Total Energy Expenditure Rochester, Minn.

    The purpose of this study is to develop the use of doubly labeled water procedures for measuring total energy expenditure, as well as run comparison testing with doubly labeled water against physiologic monitoring devices already in place. Doubly labeled water is water with extra electrons that can be traced in the urine and or saliva.

  • The Assessment of Carotid Blood Velocity Using Continuous Wave Doppler during Lower Body Negative Pressure Rochester, Minn.

    The purpose of this study is to determine the changes in carotid blood flow velocity during graded degrees of hypotension with lower body negative pressure (LBNP) using a portable Doppler developed by Flosonics.

  • The Cognitive Performance Cost of Increased Work of Breathing Rochester, Minn.

    The purpose of this study is to determine the extent to which the work of breathing impacts on cognitive performance.

  • The COVID-19-PAWS Project: An online survey examining how the COVID-19 pandemic has impacted on the physical activity habits and well-being of the general public around the world (COVID-19 PAWS) Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to examine the impact of the COVID-19 pandemic on the physical activity habits and well-being of the general public.

    The Coronavirus (COVID-19) outbreak was officially declared a pandemic on March 11, 2020 by the World Health Organization (WHO). Since then, many countries have introduced 'Social Distancing' guidelines/rules as a means of helping to stop the spread of the virus. Due to the ‘Social Distancing’ guidelines, the general population may be experiencing more sedentary behaviors and physical inactivity. Sedentary behaviors and physical inactivity are both well-known modifiable risk factors for cardiovascular disease and all-cause mortality. Thus, although Social Distancing is a necessary measure to prevent community transmission of COVID-19, we believe that a prolonged period of sedentariness may have unintended, longer-term impacts on public health and well-being in the future; health issues such as increased risk of chronic diseases that may persist well-beyond the duration of this pandemic. Therefore, it is important to determine the impact of the COVID-19 pandemic on the sedentary behaviors, physical activity levels and well-being of the general public in the United States, and worldwide. 

  • The Effects of Acute and Chronic Exercise on the Immune Phenotype in Healthy Patients Rochester, Minn.

    We are doing this study to compare how acute maximal and acute endurance exercise affect immune cell populations in the blood for different populations of healthy participants (comparing age, gender, fitness level, etc). We hope to use this information to develop a baseline understanding of how exercise affects immune system function.

  • The Effects of Atrial-Ventricular and Interventricular Delays on Cardiopulmonary Gas Exchange and Hemodynamics Rochester, Minn.

    The purpose of this study is to determine the resuts of adjusting atrial-ventricular (AV) and interventricular (VV) timing delays on cardiac hemodynamics at rest and during exercise for patients who have a CRT (cardiac resynchronization therapy) device. Most current attempts to optimize CRT are done under resting conditions and patients report symptoms during mild daily exercise.

  • The Impact of Automated Zonal Control of Indoor Air Pollutants on Cardiopulmonary Health, Sleep Quality, the Human-indoor Microbiome, and Comfort in a Simulated Apartment Rochester, Minn.

    The purpose of this study is to understand the health effects of indoor air pollution sources by focusing on controlling emissions from cooking, cleaning, and personal care product use by automating air cleaning devices, exhaust fans, and air handling unit (AHU) supply flow rates based on air quality sensor measurements.

     

  • The Influence of Nicotinamide Riboside Supplementation and Aging on Altitude Acclimatization Scottsdale/Phoenix, Ariz.

    The focus of the project is to determine if nicotinamide riboside (NR) supplementation improves the acclimatization process to high altitude. In addition, we will investigate the interaction with aging with a focus on cardio-pulmonary adaptations.

  • The Oxygen Cost of Exercise Hyperpnea in Heart Failure Rochester, Minn.

    This study is being done to: (1) develop a simple tool to assess breathing muscle performance; (2) measure the oxygen cost of breathing during exercise; (3) measure the respiratory muscle blood flow requirements of hyperpnea during exercise; and (4) to quantify the energy cost of exercise in relation to disease severity.

  • The Predictive Capabilities of Exhaled Volatile Organic Compounds (VOCs) on Heart Failure Status: A Pilot Study (HFVOC) Rochester, Minn.

    The pilot study aims to recruit 48 subjects classified as New York Heart Assosciation (NYHA) class 1-2 HF patients (n = 12), NYHA class 2-3 HF patients (n = 12), HF patients admitted to the emergency room for treatment of fluid overload (n = 12), and healthy controls (n = 12). Breath samples will be collected form these patients using a ReCIVA Breath Sampler (Owlstone Medical Ltd.) to determine the levels of exhaled volatile organic compounds (VOCs). Following enrollment and study completion, study staff will access the participants’ clinic records to obtain information about their NYHA classification, blood biomarker levels, excess fluid status, and medication history, to account for confounding exhaled VOCs as a byproduct of medication metabolism. An analysis of variance (ANOVA) will be used to determine differences in exhaled VOCs between these NYHA groups. Additionally, a generalized additive mixed model (GAMM) will be used to examine the non-linear relationships between exhaled VOCs and blood biomarkers. We hypothesize the breath biopsy samples will be sensitive enough to identify exhaled volatile organic compounds (VOCs) in healthy heart failure (HF) patients. Further, we will be capable of utilizing these exhaled VOCs to develop a “breath print” to predict worsening clinical status.

  • The Pulmonary Consequences of Participating in the UTMB and Hong Kong 100 Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF) Rochester, Minn.

    This research is being done to better understand the pulmonary consequences of completing an ultra marathon at altitude and a sea level city.

  • Training Like an Athlete as We Age, to Extend Health and Vitality into the Later Decades of Life Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine the degree of change and measure the benefits in fighting the consequences of aging, when a group of pre or early retirement individuals are put on a dedicated althlete training program and nutrition supplement.

  • Understanding the Contents of Exhaled Breath in Health and Disease Rochester, Minn.

    This research study is being done because we want to better understand the composition of exhaled breath and exhaled breath condensate in health and disease and at different stages of disease to determine if there are markers in this easy to collect sample that can help us understand disease progression and give earlier warning that health or disease status is declining and improve treatment for patients.

  • Using a Respiratory Resistance Device as a Therapeutic Modality in Treating Patients with a History of Heart Failure Scottsdale/Phoenix, Ariz.

    The purpose of this study is to investigate the potential benefits to pulmonary function using a unique respiratory “training mask” during exercise on patients with heart failure.

.