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A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess The Efficacy And Safety Of Danicamtiv In Participants With Symptomatic Genetic And Familial Dilated Cardiomyopathy
Rochester, Minn.
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM.
The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood and can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM).
The main goals of the study are:
* To assess the effect of danicamtiv on cardiac function using echocardiogram.
* To evaluate the impact of danicamtiv on exercise capacity
* To evaluate the safety and tolerability of danicamtiv
Participants will:
* Take danicamtiv or placebo every day for approximately 6 months
* Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up
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A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme’s Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
Rochester, Minn.
This study aims to identify how useful polygenic risk score (PRS) and integrated risk scoring (IRS) is in both helping doctors to treat and manage their patients and identifying people at risk of developing coronary artery disease.
The purpose of this research is to answer the following questions:
- Does PRS/IRS influence how doctors treat or manage patients?
- Does PRS/IRS identify patients with increased risk for coronary artery disease?
- Does PRS/IRS influence patient outcomes, including cholesterol levels, occurrence of heart attack, and presence of coronary artery disease risk factors?
- Does PRS/IRS affect patient understanding of risk for developing coronary artery disease?
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Heart Failure and Cardiothoracic Transplant Biorepository
Rochester, Minn.
This study is being done to develop a serum and tissue bank for future research of patients with heart failure, mechanical circulatory support and/or cardiothoracic transplants. This blood/tissue will be used for three principle purposes: (1) laboratory tests which will be available in the future but that are not currently available and which may be of benefit to the patient, (2) review of previous patient laboratory results made necessary by development of a new disease process by the patient, and (3) future unspecified research purposes.
Contact Us for the Latest Status
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A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess The Efficacy And Safety Of Danicamtiv In Participants With Symptomatic Genetic And Familial Dilated Cardiomyopathy
Jacksonville, Fla.
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM.
The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood and can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM).
The main goals of the study are:
* To assess the effect of danicamtiv on cardiac function using echocardiogram.
* To evaluate the impact of danicamtiv on exercise capacity
* To evaluate the safety and tolerability of danicamtiv
Participants will:
* Take danicamtiv or placebo every day for approximately 6 months
* Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up
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Machine Learning Guided Precision Genetic Testing for Identification of Monogenic Cardiovascular Disorders (GENE-CARES) (GENE-CARES)
Rochester, Minn.
The purpose of this study is to validate a precision genetic testing approach guided by machine learning (ML)-based models.
Closed for Enrollment
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A Proof of Concept Study to Determine the Efficacy of Entresto™ in HFpEF Based on Circulating Neprilysin Levels: The Circulating NEP and NEP Inhibition (CNEPi) Study (CNEPi)
Rochester, Minn.
To determine biomarker responses to Entresto™in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and who have high or low serum neprilysin (NEP) levels.
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A PROSPECTIVE MULTINATIONAL STUDY OF THE NATURAL HISTORY OF PARTICIPANTS WITH BAG3 MUTATION ASSOCIATED DILATED CARDIOMYOPATHY
Rochester, Minn.
The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart becomes enlarged. This makes it hard for the heart to pump enough blood for the body.
The study is seeking up to about 35 participants who have:
* BAG3 mutation (change in the gene) that causes or is likely to cause dilated cardiomyopathy
* NYHA (New York Heart Association) Class I-IV at screening (Stage B-D)
* Left Ventricular Ejection Fraction less than or equal to 50% (meaning reduced heart function)
All participants in this study will receive their usual treatment. The investigators will observe the natural progression of people who have BAG3 DCM. This will help the investigators better understand the disease and aid in future research.
Participants will take part in this study for one year. During this time, participants will visit the site at least 4 times (about every 3 months). Participants will undergo study procedures and give information about their health. These procedures will include a physical exam, cardiac magnetic resonance imaging, echocardiography, ECG monitoring, activity monitoring, cardiopulmonary exercise testing, and blood tests. Participants will answer questions about health and quality of life. The study team will also call participants about 1 time over the phone.
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An Open-Label, Exploratory Study Of The Safety And Preliminary Efficacy Of Danicamtiv In Stable Ambulatory Patients With Primary Dilated Cardiomyopathy Due To Either MYH7 Or TTN Variants
Rochester, Minn.
The purpose of this study is to establish safety and preliminary effectiveness of treatment with MYK-491 in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants .
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Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial – Pilot Study)
Rochester, Minn.
The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into SOC recommendations (screening TTE).
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Development Of An Evidenced-Based Tool For Prediction Of Sudden Death In Patients With Non-Ischemic Cardiomyopathy (NICM-Registry)
Rochester, Minn.
This study is an observational study to determine predictors of sudden cardiac death or appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be followed for 36 months for the occurrence of sudden cardiac death
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The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to develop an RNA-seq based peripheral blood assay predictive of inflammation/rejection on allograft biopsy in adult heart transplant recipients.
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