The purpose of the study is to determine whether FINErenone reduces total (first and future) Heart Failure events and cardiovascular death compared with placebo in patients hospitalized with acute decompensated Heart Failure with Mid-Range Ejection Fraction and Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 36 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities such as vitals, blood tests and questionnaires. There will be 8 visits as part of participation in this clinical trial. Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like flipping a coin). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.
You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.
The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.
Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.
The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.
The purpose of this study is to collect blood specimens and determine the levels of natriuretic peptides in the blood in patients that are presenting with a suspicion of new onset or worsening symptoms of heart failure. Blood specimens collected during this study will be used to support expanded development of a blood test that can help physicians diagnose heart failure.
The blood test (Access BNP Assay) being developed will measure natriuretic peptides that are released into the blood when the heart muscle is stretched and working too hard. This information is being used to develop a better blood test(s).
Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.
To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.
The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.
The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.
This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.
The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.
This is a multi-center study that we have been invited to join that will evaluate the LVAD pump function in relation to adverse events. We are the 8th largest implanting center for LVADs in the United States and feel it is important to be a part of this.
This study is enrolling subjects with an abnormal heart rhythm called ventricular tachycardia (VT - rapid heart beat coming from the bottom of the heart) that has come back despite treatment. This is a randomized study meaning subjects will be assigned to one of two groups and then undergo either a standard catheter ablation or a new treatment called cardiac radioablation for their VT. You will have a 50:50 chance of being assigned to either group. A standard catheter ablation is done by placing catheters (long hollow tubes) into a large blood vessel at the top of the leg, guiding them to the heart to first identify the signals causing the VT and then use radiofrequency (heat) energy to burn and stop these signals to stop the VT. The cardiac radioablation is an investigational treatment meaning it is not yet approved for routine clinical use by the Food and Drug Administration (FDA). Cardiac radioablation is performed in the radiation oncology department and uses radiation therapy to treat the signals causing the VT. Participation in this study will last up to 5 years and inlcude about 15 visits. Study related procedures include medical record review and data collection, electrocardiogram (tracing of heart's electrical activity), echocardiogram (ultrasound test of the heart), CT scans, blood work, questionnaires, implantable cardioverter defibrillation (ICD - device implanted in your chest that monitors and treats abnormal heart rhythms), and ablation procedure per randomization. Risks include fatigue, changes in the appearance of the lungs in the cardiac radioablation group, fatigue, pain, low or high blood pressure or excessive bruising or bleeding at the catheter insertion side in the cardiac ablation arm. There are also study procedure related risks, and risks that are not known. There is potential benefit to you and to others in learning how to better treat others in the future with this condition.
This study is an open label extension study for those who participated in the ION 682884-CS2 clinical trial for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a disease caused by change in a protein called transthyretin (TTR) which can result in a build up of this protein in parts of the body including the heart. This build up is called an amyloid deposit, and when this occurs in the heart it can lead to a condition called cardiomyopathy. This study involves the medication eplontersen, which is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration (FDA). Eplontersen is aimed at preventing production of the TTR protein to slow or reverse disease progression. Eplontersen is given as an injection under the skin in the upper arm, stomach or thigh. This study will last about 3 1/2 years and include 16 clinic visits. Study procedures include physical exams, blood work, questionnaires, hall walk tests, electrocardiograms (tracing of the heart's electrical activity), echocardiogram (ultrasound test of the heart) and taking a Vitamin A supplement.