Amritsar

Researchers are evaluating the safety and effectiveness of centhaquine citrate (LYFAQUIN193), a new drug designed to treat hypovolemic shock, which is a serious condition caused by severe blood or fluid loss. This phase IV, open-label, multi-center study involves adult patients aged 18 years or older who are experiencing hypovolemic shock with low blood pressure and elevated blood lactate levels. Centhaquine has shown promising results in animal models by improving blood pressure, cardiac output, and reducing mortality through its action on specific adrenergic receptors. Participants will receive centhaquine alongside standard shock treatments such as fluid resuscitation, vasopressors, and endotracheal intubation. The drug will be given intravenously at a dose of 0.01 mg/kg in 100 mL of normal saline over one hour. If blood pressure remains low, an additional dose may be given after 4 hours, with a maximum of three doses within 24 hours. Centhaquine administration can continue for up to two days after enrollment, with close monitoring throughout their hospital stay. During the study, patients will be monitored until discharge or for up to seven days from enrollment. Researchers will assess safety by tracking adverse and serious adverse events, as well as efficacy by measuring blood pressure, lactate levels, base deficit, and survival rates. Statistical analyses will compare patient outcomes, and the results will be presented with detailed data summaries to evaluate the drug's safety and benefits when added to standard care for hypovolemic shock.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.