Haddon Heights

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This clinical trial is prospective, multi-center, randomized, quadruple-blind, and sham-controlled, aiming to assess CCM therapy delivered through the OPTIMIZER Smart Mini System. The study is divided into two parts: Part I focuses on safety and effectiveness based on functional capacity and health status, while Part II focuses on clinical outcome data. Participants will have the OPTIMIZER Smart Mini System implanted and then be randomized in a 2:1 ratio to either have CCM therapy turned ON or OFF for the first 18 months, during which the trial is blinded. CCM therapy is programmed to deliver seven one-hour treatment phases evenly spaced over 24 hours. After 18 months, participants initially assigned to the CCM OFF (sham) group will have the therapy turned ON. Subjects enrolled in Part I will continue to be followed through Part II to contribute data for safety and effectiveness evaluation. Throughout the study, participants will undergo various assessments including the 6-minute walk test and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to measure changes in functional capacity and health status at 6 months. Safety will be monitored by tracking device- or procedure-related complications up to 12 months. The study also measures a composite of mortality, morbidity, and health status outcomes over an 18-month period. Follow-up and monitoring continue throughout the study duration to capture these outcomes and ensure participant safety.

Researchers are evaluating inclisiran, a subcutaneous injection given twice yearly, to see if it can prevent major cardiovascular and limb events in patients undergoing percutaneous coronary or peripheral arterial revascularization. This Phase 4, randomized, double-blind study includes patients with symptomatic coronary artery disease or peripheral artery disease who have recently had successful revascularization procedures. The trial aims to assess the real-world effectiveness of inclisiran alongside usual care in a typical U.S. patient population with atherosclerotic cardiovascular disease. Participants will be randomly assigned to receive either 300 mg inclisiran or a matching placebo by subcutaneous injection on Day 1, Month 3, and then every 6 months thereafter. The first dose is given within 14 days of a successful percutaneous coronary or peripheral endovascular intervention. Both groups will continue to receive standard medical care as directed by their physicians. The study plans to enroll about 6,000 participants and treatment duration may last up to approximately 45 months. During the study, researchers will monitor participants for the occurrence of major adverse cardiovascular events and major adverse limb events for up to about 4 years. Participants will have regular follow-up visits and safety assessments throughout the study period, which is designed to continue until around 2,380 primary events have occurred or at least half the participants have completed 36 months of follow-up. Outcome measures focus on the number of cardiovascular and limb events after the procedures, providing important information on the long-term impact of inclisiran in this patient group.

Researchers are gathering real-world clinical data on the use of radiofrequency catheter ablation technologies to treat patients with symptomatic Paroxysmal and Persistent Atrial Fibrillation. This observational registry aims to evaluate the clinical outcomes, procedural efficiency, safety, and long-term effectiveness of novel ablation devices such as THERMOCOOL SMARTTOUCH and its variants in these patient groups. The study focuses on understanding how well these ablation treatments work in everyday clinical settings beyond controlled trials. Participants undergo ablation treatment using radiofrequency technologies, with procedures performed at selected sites following their standard care practices. Patient assessments are scheduled at multiple time points: before the ablation, during the procedure, and at follow-up visits approximately 10-12 weeks, 6 months, and 1 year after ablation. Monitoring includes heart rhythm tracking and evaluations of arrhythmia recurrence, medication usage, and related symptoms. During the study, participants receive comprehensive evaluations including echocardiograms, medical history reviews, arrhythmia monitoring with continuous heart rhythm devices, and physician assessments. Researchers measure effectiveness at 90 days and 12 months, along with safety outcomes shortly after the procedure and during follow-ups. The total follow-up period spans one year to assess long-term treatment impact and patient quality of life improvements.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.

Researchers are evaluating the safety and effectiveness of the CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation who are at high risk of stroke or systemic embolism. The study aims to show that the CLAAS device performs at least as well as the other devices in preventing stroke and related complications. Eligible patients will be randomly assigned to receive either the CLAAS device or one of the other devices and will be monitored for five years following implantation. Participants will receive one of the three left atrial appendage closure devices: CLAAS, WATCHMAN, or Amulet. The devices are implanted to close off the left atrial appendage, reducing the risk of stroke. After the procedure, patients will be followed for up to five years to assess long-term safety and device performance. The study includes an initial period to observe procedure-related complications, bleeding events, and all-cause death within 12 months, as well as ischemic stroke and systemic embolism over 18 months. During the study, participants will undergo regular evaluations and follow-ups to monitor their health and device effectiveness. Researchers will track any complications related to the procedure, bleeding events, strokes, and overall survival. Safety will be closely monitored through clinical assessments and imaging as needed. Patient adherence to medication regimens and follow-up visits will also be checked throughout the study duration to ensure accurate and comprehensive data collection.