Jaffna

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.

Researchers are evaluating the effects of the SGLT2 inhibitor dapagliflozin compared to metformin on the annual decline in kidney function, measured by eGFR, in people with Type 2 Diabetes. This Phase 3, randomized, double-blind trial is conducted in primary care and community sites in Australia and tertiary care centers in Sri Lanka. The purpose is to understand which first-line therapy may better prevent kidney decline in this population. After a 4-week active run-in period, participants will be randomly assigned to one of two groups one group will take dapagliflozin 10 mg once daily with placebo metformin tablets, and the other group will take metformin XR 2000 mg once daily with placebo dapagliflozin tablets. Treatment will continue for 2 years under quadruple masking to maintain study integrity. During the study, participants will undergo assessments including kidney function tests eGFR, serum creatinine, urine albumin creatinine ratio, blood sugar measurements HbA1C, fasting glucose, blood pressure monitoring, body weight check, and quality of life evaluations using the EQ-5D-5L. Mental health symptoms such as anxiety and depression will also be measured with the HADS questionnaire. The primary outcome is the rate of eGFR decline over 24 months, with safety and other health indicators monitored throughout the study period.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.