Search Bar & Filters
Found 4 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effects of intravenous ferric carboxymaltose FCM compared with a placebo on death risk, heart failure events, NT-proBNP levels, and quality of life in patients who recently had an acute myocardial infarction AMI and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess these outcomes over a follow-up period ranging from 8 to 36 months. Participants are randomly assigned to receive either an intravenous 15-minute infusion of 1000 mg FCM diluted in saline or a placebo infusion of saline alone. The first dose is given on the day of randomization, with follow-up visits at 4, 8, 12, 18, 24, and 30 months to reassess participants and possibly repeat treatment if safety criteria are met. During the study, participants undergo evaluations including monitoring of death rates, heart failure events such as unplanned hospitalizations or emergency visits, changes in NT-proBNP concentration, and quality of life measured by the EQ-5D questionnaire. Safety and treatment effects are tracked throughout the follow-up period, which can last up to 36 months from the start of participation.
Actively Recruiting
This research is an open-label, multi-center study designed for adults who have previously participated in Novartis clinical trials involving remibrutinib treatment for dermatological or allergology conditions. It aims to provide continued access to remibrutinib for participants benefiting from the drug and to collect long-term safety data over up to three years. Participants will continue receiving remibrutinib tablets at the same dose and regimen they had in their prior study. There is no screening period after consent and eligibility confirmation at the enrollment visit, participants begin treatment immediately. They will return to the study center at least every 16 weeks for medication resupply but can visit earlier if needed. Treatment continues up to three years or until specific stopping criteria are met, such as loss of benefit or withdrawal. Throughout the study, participants will have regular visits to monitor safety, including tracking of adverse events. Researchers will assess the number of participants experiencing adverse events or serious adverse events over approximately seven years. The study ensures ongoing evaluation of participant well-being and allows for withdrawal at any time, with no cost for study-related care.