This is a 3 month study for pediatric patients between the ages of 6 months and 18 years that have a current diagnosis of heart failure. This study will compare the use of the medication finerenone to placebo. During the study, participants will continue to receive their standard of care therapy according to pediatric heart failure guidelines. At the end of the 3 month study period, participants will have the option to enroll in a 9 month open label extension.
The PRE-EMPT study is designed to identify people who may have early signs of heart disease even though they are considered to be at low risk for heart problems. Participants will undergo specialized heart scans to look for plaque buildup in the arteries that supply blood to the heart. Individuals found to have early plaque may be invited to participate in a treatment phase of the study. In this phase, participants will receive either study medications (rosuvastatin and/or colchicine) or placebo tablets and will also receive support for healthy lifestyle behaviors through a digital health platform. Patients will be randomized to one for four treatment groups. Researchers will follow participants for approximately two years to determine whether these treatments and lifestyle interventions can slow or reduce plaque buildup in the heart arteries. Information gained from this study may help improve strategies for detecting and treating early heart disease in the future.
Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, 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 (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.
This study is enrolling subjects with heart failure and a preserved fraction meaning the heart is too stiff to fill properly to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.
This is a post approval study for those being implanted with the WiSE System. Data will be collected from your medical records including medical history, medications, the implant procedure, and device check as well as routine follow up visits, and you will be asked to complete a questionnaire at 3 visits. Participation in this post approval registry will last about 5 years. There is a risk of loss of confidentiality.
This study is enrolling subjects with severe aortic regurgitation (when blood leaks back in the heart because the aortic valve does not close properly) into a randomized study. Typically valve replacement is performed to correct this condition. This study will compare a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to open heart aortic valve surgery (SAVR). the JeneValve Trilogy Heart Valve System is considered investigational meaning it has not been approved yet by the Food and Drug Administration (FDA). A TAVR procedure is done by accessing a large blood vessel at the top of your leg and delivering the new valve as opposed to open heart surgery. This study will randomize subjects in a 1 to 1 fashion to TAVR or SAVR. Randomized means assigned by chance, so you will have a 50% chance of being assigned to the TAVR group and a 50% chance of being assigned to the SAVR group. The SAVR group will have the aortic valve replacement done by open heart surgery using a commercially available device.
Participation in this study will last about 10 years and include 15 visits. Study related testing includes physical exam, echocardiograms (ultrasound test of the heart), electrocardiograms (recording of heart's electrical activity), 6 minute hall walk, bloodwork and a questionnaire.
There are risks including risks related to the procedure and to study testing. There may be no benefit but the information learned may help in treating others in the future.
This study is seeking subjects who have been diagnosed with and may be receiving medical treatment for mitral valve disease. The purpose of this registry is to collect data to better understand the progression of mitral valve disease and the effects of different treatments on the disease and patient health. If you agree to participate in this registry, your medical data will be collected including your medical history, certain background information, and certain test images/results. This registry will also collect information about current and future treatments for your mitral valve disease and data from future disease-related follow-up visits. Data will be collected for up to 24 months. There are no additional visits or any additional testing required for this registry.
This study will continue using the study drug levosiminden to determine if it can help people with the heart failure with preserved ejection fraction with pulmonary hypertension (HFpEF-PH). Levosimenden is an investigational drug. Investigational means that this drug is not yet approved for use in any settings outside of clinical research studies like this one. This drug is thought to assist in helping with decreasing your heart failure symptoms and increase your quality of life.
Participation in this study will last up to 60 month and will consist of about 13 clinic visits. Some tests required include physical exams, and dispensing of study medication, bloodwork.
This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the Horizon 360 System which is investigational meaning it has not yet been approved for use by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.
This study will last about 1 year and include up to 8 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.
This study is being done to learn more about the study drug known as AZD0780. AZD0780 is investigational meaning it has not yet been approved for commercial uses by the Food and Drug Administration (FDA) but has been approved for use in this study. This study will evaluate the efficacy, safety and tolerability of AZD0780. AZD0780 is taken once daily by mouth. This is a randomized study which means you will be assigned by chance, like flipping a coin, and you will have a 1 in 2 chance of being assigned to the study drug or placebo. Placebo is a substance that looks like the study drug but has no active ingredients. Neither you nor your study doctor or study team will know if you are assigned to study drug or placebo.
Participation in this study will last up to 4.5 years and include up to 15 visits. Study related procedures include medical history collection, physical exams, electrocardiogram (ECG – a test that records the heart's electrical activity), questionnaire and bloodwork. There are risks related to the study drug including increased blood pressure, shortness of breath and vomiting.