Egg Harbor City

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

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 designed as a multi-center, randomized, quadruple-blind, sham-controlled study to compare CCM therapy delivered through the OPTIMIZER Smart Mini System against a sham control. The trial includes two parts the first focuses on functional capacity and health status, while the second examines clinical outcomes. Participants will have the OPTIMIZER Smart Mini System implanted and be randomly assigned in a 21 ratio to either receive active CCM therapy CCM ON or sham therapy CCM OFF for the first 18 months. CCM therapy involves delivering seven one-hour treatment phases spread evenly over each 24-hour period. After 18 months, those initially in the sham group will have CCM therapy activated. Part I of the trial enrolls 450 participants, who will be followed through Part II, which includes up to an additional 1,050 participants. During the study, participants will undergo screening and baseline evaluations before device implantation. Researchers will assess changes in walking distance using a 6-minute walk test and health status via the Kansas City Cardiomyopathy Questionnaire at 6 months. Safety will be monitored by tracking device- or procedure-related complications over 12 months. The study will also evaluate a composite of mortality, morbidity, and health status outcomes up to 18 months. The total duration of participant involvement spans up to 18 months with ongoing follow-up and monitoring.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

This trial evaluates inclisiran, a subcutaneous injection given twice yearly, for preventing major cardiovascular and limb events in patients who have undergone percutaneous coronary intervention PCI or peripheral endovascular intervention PVI. The study focuses on patients with atherosclerotic cardiovascular disease, including coronary artery disease and peripheral artery disease, aiming to assess inclisirans role alongside standard care in real-world settings. It is a randomized, double-blind, placebo-controlled, phase 4 study involving about 6,000 participants. Participants will receive either 300 mg of inclisiran or a matching placebo by subcutaneous injection on Day 1 within 14 days of their intervention, at Month 3, and then every 6 months thereafter. The study compares inclisiran to placebo while all participants continue their usual care prescribed by their physicians. The treatment duration varies with event accrual and follow-up but is expected to last approximately 4 years, with individual participants receiving treatment for up to about 45 months. Throughout the study, participants will be regularly monitored for major adverse cardiovascular events MACE and major adverse limb events MALE up to about 4 years from randomization. Additional assessments include tracking cardiovascular death, all-cause death, and venous thromboembolic events. The study includes safety monitoring and follow-up visits to evaluate the outcomes and adherence to the intervention and usual care during the entire study period.

Researchers are evaluating the safety and effectiveness of the MagicTouch14 Sirolimus-coated balloon compared to plain old balloon angioplasty POBA in treating coronary in-stent restenosis ISR, which occurs when previously placed drug-eluting stents become narrowed again. This prospective, randomized, two-arm, single-blind superiority trial involves subjects with prior drug-eluting stent implantation who require percutaneous coronary intervention PCI for ISR. The study aims to establish whether the MagicTouch device improves treatment outcomes for coronary artery lesions. Participants will be randomly assigned in a 21 ratio to receive either the MagicTouch Sirolimus-coated balloon or POBA during PCI to treat the ISR lesion. Before treatment, patients undergo medical history review, physical exams, lab tests, and ECGs. Blood samples will be collected before and after the procedure to assess cardiac biomarkers such as troponin T. During hospitalization, patients receive clinical assessments and ECGs biomarker samples are taken at specified intervals to monitor heart muscle injury. After discharge, patients have follow-up visits at 30 days, 6 months, 12 months, and annually up to 5 years, which include ECGs, blood tests, medication reviews, and adverse event monitoring. Angiograms performed within the first year will be reviewed by a blinded core lab to evaluate lesion status. Participants will be involved in scheduled clinical assessments, laboratory testing, and imaging evaluations to track heart function and treatment outcomes. Researchers will measure the primary outcome of target lesion failure at 12 months and multiple secondary outcomes related to cardiovascular events, revascularization, mortality, myocardial infarction, bleeding, and procedural success up to 5 years. The study includes safety monitoring through biomarker analysis and ECGs during hospitalization and detailed follow-up visits extending through 60 months post-procedure to assess long-term effects.

Researchers are evaluating the safety and effectiveness of the MagicTouchTM Sirolimus-Coated Balloon in treating small blood vessels 2.75 mm or less in diameter in patients with coronary artery disease. This multicenter, randomized, single-blind study aims to compare this drug-coated balloon with drug-eluting stents in patients needing percutaneous coronary intervention PCI for lesions in small native coronary arteries. The trial plans to enroll about 1605 subjects across up to 50 sites in North America, with additional sites in Europe and South America. Participants will be randomly assigned in a 21 ratio to receive either the MagicTouchTM sirolimus-coated balloon or a drug-eluting stent approved by the FDA either Everolimus or Zotarolimus eluting stents. The treatment targets a single lesion in a major coronary artery or side branch, with lesion size limits between less than 2.75 mm and up to 34 mm in length. Lesion preparation must be successful prior to treatment. The study includes a detailed follow-up period assessing outcomes up to 60 months, focusing on safety and performance measures. During the study, participants will provide medical history and undergo physical exams, lab tests, and a 12-lead ECG within 7 days before the procedure. Women of childbearing potential will have pregnancy tests before treatment. Patient-reported angina symptoms will be tracked using the Seattle Angina Questionnaire at baseline, 30 days, 6 months, and 12 months, with further follow-up visits to monitor target lesion failure and other cardiovascular events for up to five years. The primary outcome is target lesion failure at 12 months after intervention.

This research aims to provide additional information on the LimFlow System for treating late-stage chronic limb-threatening ischemia in patients who cannot have standard endovascular or surgical limb salvage procedures. The study focuses on using a minimally invasive approach to create an arteriovenous connection in the below-the-knee blood vessels to arterialize the pedal veins and improve blood flow in the affected limb. Participants will be treated with the LimFlow Stent Graft System, which creates an arteriovenous fistula in the target limb through a percutaneous, endovascular procedure. This single-arm, multi-center study involves one treatment group receiving this device to assess its use and effects in this patient population. During the study, participants will undergo assessments including wound healing evaluations, limb salvage status, and patency of the treated vessels at multiple time points up to 12 months. Researchers will monitor amputation-free survival at 6 months as the primary outcome and assess other clinical and procedural outcomes such as technical success, wound size reduction, and safety measures. Participants will be followed for ongoing evaluation of treatment impact and safety.