Haddon Heights

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.

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.

This research evaluates the real-world safety and long-term effectiveness of catheter ablation procedures in treating patients with paroxysmal atrial fibrillation PAF, persistent atrial fibrillation PsAF, and ventricular arrhythmias VA. The study is an observational, prospective, multi-center registry collecting clinical data from the use of commercially available CARTO technologies by Biosense Webster, Inc. These procedures are performed under usual care by healthcare practitioners. Participants receive catheter ablation using Biosense Websters CARTO devices such as THERMOCOOL SMARTTOUCH, QDOT MICRO, and VARIPULSE catheters. The registry includes patients with symptomatic PAF or PsAF who are candidates for ablation, as well as patients with documented ventricular arrhythmias suitable for catheter ablation. The ablations follow standard care practices at participating sites, and future new ablation technologies may also be included as they become available. Throughout the study, participants undergo routine baseline and follow-up evaluations aligned with standard care without extra visits required by the registry. Researchers monitor outcomes including procedural efficiency, acute safety within 30 days post-ablation, arrhythmia recurrence after a 90-day blanking period, and long-term effectiveness up to 12 months. Patient-reported symptoms, medication usage, and clinical scores such as CHA2DS2VASC are also collected to assess the overall impact of the ablation procedures.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.

Researchers are evaluating the safety and performance of the Conformal CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation at high risk of stroke. The study aims to establish that the CLAAS device is not worse than these other devices in preventing stroke and related complications. Participants eligible for the study will be randomized to receive either the CLAAS device or one of the comparator devices and will be followed for a total of five years after implantation. Participants will undergo a procedure to implant one of the left atrial appendage closure devices via a catheter-based system. The study includes two groups one receiving the CLAAS device and the other receiving either the WATCHMAN or Amulet device. After implantation, patients will be monitored closely for safety and effectiveness outcomes, including procedure-related complications and stroke prevention over time. The study involves careful follow-up visits and assessments to track device success and any adverse events. Throughout the study, participants will have regular evaluations to monitor outcomes such as procedure complications, death, major bleeding, ischemic stroke, and systemic embolism, with primary outcome assessments at 12 and 18 months and extended follow-up up to five years. Success of the device placement and technical performance will also be assessed at various time points. Participants will be asked to follow medication regimens and attend follow-up visits to ensure proper monitoring. The total duration of participation includes post-procedure monitoring and long-term outcome measurement extending to the end of the study period.