The purpose of this research study is to evaluate the safety and effectiveness of tirzepatide compared to placebo (an inactive substance) in the treatment of individuals with Heart Failure with Preserved Ejection Fraction (HFpEF) and obesity.
Participants will undergo a screening visit where they will have a physical exam to asses health and blood will be drawn. If the blood tests show that a participant qualifies to continue, then they will be randomly assigned to either tirzepatide or placebo. Each participant will have a 50:50 chance of being on tirzepatide (like the flip of a coin.) Both tirzepatide and placebo will be supplied as a single dose in an injectable pen device. Subjects will inject the study drug under the skin (or subcutaneous) once a week with the injectable pen. Participation will last at least 52 weeks and may last up to 120 weeks.
Tirzepatide has been proven to provide significant body weight loss and improvement of fat and sugar metabolism in patients with type 2 diabetes. Body weight percent reduction in this study is estimated to be 15% to 16%.
Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.
This study will examine a new ablation catheter for the treatment of drug resistant paroxysmal atrial fibrillation. Atrial fibrillation is an irregular heart beat that causes the upper chambers of the heart to beat out of sync. Paroxysmal means this irregular heart beat starts and stops on its own. When medications used to keep your heart in rhythm no longer work or cause unwanted side effects an ablation procedure is recommended. For this study the FARAPULSE™ Pulsed Field Ablation System including the FARAWAVE™ Pulsed Field Ablation Catheter will be used. This system including the catheter are investigational meaning it has not been approved for use by the US Food and Drug Administration. (FDA) Participation in this study will last about a year and will include up to five in person visits and four remote/telephone visits.
This study is for patients who are currently hospitalized with heart failure, a condition where the heart muscle is weakened and cannot pump blood effectively, and have low blood pressure. This study involves an investigational, not yet approved by the US Food and Drug Administration (FDA) intravenous (given into a vein) medication that is being studied to see if it can help increase blood pressure. The study involves a screening visit, randomization which is where either the study medication or placebo is assigned randomly, medication or placebo infusion for 24 hours, visits at day 2,3 and 4 and then a final visit at day 30.
Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.
The purpose of this study is to evaluate the safety and effectiveness of ION-682884 and determine if it can help people with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). ION-682884 is an investigational drug. "Investigational" means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help your cardiomyopathy.
If you meet the requirements and agree to participate in this study, you will receive subcutaneous (under the skin) injections of either ION-682884 or placebo once every 4 weeks from week 1 through week 117.
Your participation in this study will last approximately 36 months and will consist of clinic visits and follow up visits at home.
This study is looking for volunteers who are having the Heart Mate 3 (HM3) Left Ventricular Assist Device (LVAD) implanted for treatment of heart failure. The study will collect medical information and patient experiences who have received treatment with the HM3. The traditional method to implant the HM3 is an incision in the middle of the chest through the breastbone (also called the sternum). This study will collect data if you have the Heartmate 3 implanted using a less invasive approach. Study participants will attend 8 visits over the course of 6 months.
Central sleep apnea occurs when the brain fails to send a signal to the muscles that control breathing during sleep causing brief pauses in breathing. It is widely believed that treatment of central sleep apnea may improve heart failure and quality of life. The goal of this study is to evaluate the effectiveness of oxygen treatment in patients with both central sleep apnea and heart failure.
The purpose of this study is to use an investigational device called the Atellica® VTLi™ test system to test a substance in your blood called troponin that may help with the diagnosis of a heart attack