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327 recruiting in MN
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Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Blood Pressure · Heart Disease · Hypertension (HTN)

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Rochester, MN18+ yrsAll genders
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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Tricuspid Regurgitation · Tricuspid Valve Insufficiency · Tricuspid Valve Disease

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Maplewood, Rochester, MN18+ yrsAll genders
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AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction

Aortic Stenosis · Diastolic Dysfunction

Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.

Rochester, MN60+ yrsAll genders
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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Heart Failure With Preserved Ejection Fraction · Heart Failure With Mildly Reduced Ejection Fraction · Obesity

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Mankato, Maplewood +more, MN18–99 yrsAll genders
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Techquity by FAITH!

Health Equity · Cardiovascular Diseases

The goal of this clinical trial is to engage African-American churches via an established community-academic partnership (FAITH! Program) to build capacity to promote cardiovascular health and digital health equity in African-American faith communities. There are 3 study aims: Aim 1: Co-design a culturally tailored digital health equity toolkit with community members Aim 2: Train a network of Digital Health Advocates (DHAs) in digital health equity and cardiovascular health promotion Aim 3: Test the impact of a DHA-enhanced mobile health intervention (the FAITH! App) on cardiovascular health and digital health readiness among participants In Aim 1, participants will attend a series of focus groups to share their input on a digital health equity curriculum that will be condensed into a toolkit. In Aim 2, DHAs will be trained using this toolkit as well as a community health advocacy curriculum to learn how to promote digital health readiness and cardiovascular health in their communities. Finally, Aim 3 will be a randomized controlled trial where participants will use the FAITH! App to improve their cardiovascular health. Some participants will have the added support of a DHA, and the control group participants will use the app with no additional support to test whether the DHA support is associated with a more significant improvement in cardiovascular health.

Rochester, MN18+ yrsAll genders
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Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Acute Coronary Syndrome

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Coon Rapids, Duluth +more, MN45+ yrsAll genders
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Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant

Amyloidosis · Amyloid Cardiomyopathy · Transthyretin Amyloidosis

Transthyretin amyloidosis (ATTR) is a disease where the normally occurring transthyretin (TTR) protein falls apart and forms amyloid, a sticky plaque-like substance that accumulates in different organs in the body and can cause damage to the organ. There are two ways that the TTR protein can fall apart. One way occurs as a person ages, where the normal TTR protein can fall apart and form amyloid that may no longer be sufficiently cleared by the body. This type of ATTR is known as wild-type ATTR (ATTRwt). The other way occurs when a person inherits a defective TTR gene that causes the TTR protein to spontaneously fall apart. This form of the disease is known as variant ATTR (ATTRv) and can be detected in adults by a genetic test of their TTR gene before they age. Amyloid build-up in the heart causes the heart wall to become thick and stiff and can result in heart failure and even death. Accumulation of TTR amyloid in the heart is known as transthyretin amyloid cardiomyopathy or ATTR-CM. Amyloid can also deposit in the nerve tissues leading to nerve problems. Accumulation of TTR in the nerves is known as transthyretin amyloid polyneuropathy or ATTR-PN. Acoramidis is an experimental drug designed to bind tightly to TTR in the blood and stabilize its structure, so it does not form the harmful amyloid plaques that can cause damage to organs. This study is intended to determine if treatment with acoramidis in participants with ATTRv who have not yet developed any symptoms of disease can prevent or delay the development of ATTR-CM or ATTR-PN disease. If adults with an inherited defective TTR gene are treated early before any of the symptoms of disease have developed, it may be possible to delay the onset or prevent the disease entirely.

Rochester, MN18–75 yrsAll genders
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Abatacept for the Treatment of Giant Cell Arteritis

Giant Cell Arteritis

This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.

Rochester, MN50+ yrsAll genders
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A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) · Idiopathic Inflammatory Myositis (IIM) · Systemic Sclerosis (SSc)

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Minneapolis, MN12–70 yrsAll genders
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Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

Heart Failure - NYHA II - IV

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Duluth, Saint Cloud, MN18+ yrsAll genders
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Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

Resistant Hypertension

HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications

Rochester, MN22–80 yrsAll genders
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Q702 for the Treatment of Patients With Hematologic Malignancies

Hematopoietic and Lymphatic System Neoplasm · Histiocytic Sarcoma · Malignant Histiocytosis

This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies.

Rochester, MN18+ yrsAll genders
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The Co-Op @ HeartWorks

Congenital Heart Disease

This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.

Rochester, MN0+ yrsAll genders
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A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma

Multiple Myeloma · Myeloma · Myeloma Multiple

A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).

Rochester, MN18+ yrsAll genders
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Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy

Ventricular Tachycardia · Ischemic Cardiomyopathy

Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.

Rochester, MN18+ yrsAll genders
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Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke

Stroke · Ischemic Stroke · Hemorrhagic Stroke

The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count. Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time. They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).

Minneapolis, MN18+ yrsAll genders
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