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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

Age: 18Years +All GendersPhase 3
639 locations
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Actively Recruiting

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Age: 18Years +All GendersPhase 3
653 locations
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Actively Recruiting

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Age: 18Years - 100YearsAll GendersPhase 3
492 locations
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Actively Recruiting

Researchers are evaluating the effects of individualized sodium management during hemodialysis compared to standard treatment in patients with end-stage renal disease undergoing dialysis. The study aims to assess how controlling sodium affects weight gain between dialysis sessions, fluid balance, blood pressure stability during dialysis, and adverse events related to dialysis. It also collects data on patients' quality of life and overall wellbeing. Participants will receive 12 weeks of treatment with either standard hemodialysis or hemodiafiltration using the 6008 HD dialysis machines, with or without the sodium control feature enabled. Each patient will undergo three dialysis sessions per week, totaling 36 sessions during the study. The treatments involve either sodium zero-diffusive management or standard dialysis without sodium control. Throughout the 12-week period, patients will be monitored for weight gain between sessions, fluid status, blood pressure stability during dialysis, and any dialysis-related complications. Researchers will collect clinical and performance data as well as information on quality of life. This monitoring aims to understand the impact of sodium management on patient health and dialysis outcomes.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the effects of a 21-day comprehensive spa care program on adults aged 40 to 70 years with nephrological and urological conditions such as recurrent and chronic kidney inflammation, nephrolithiasis, nephrocalcinosis, post-surgery recovery, and chronic prostatitis. This prospective, single-arm study is conducted at a spa facility in Mariánské Lázně, Czech Republic, where the natural healing resources of the spa are used as part of routine clinical care. The goal is to objectively assess changes in clinical, laboratory, and patient-reported outcomes before and after treatment. Participants receive a standard 21-day spa treatment that includes drinking mineral spring water three times daily, mineral water baths, peloid therapy (mud applications), carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy with nutritional counseling. Patients undergo a total of 63 therapeutic procedures during their stay. Additional treatments may be prescribed individually by the spa physician based on patient needs. Assessments occur at the start (days 1-3) and end (days 19-21) of treatment and include physical exams, abdominal and urinary tract ultrasound, blood and urine sampling for laboratory analysis, body composition measurement using bioelectrical impedance analysis, and psychometric questionnaires. Researchers measure changes in kidney function markers, electrolytes, microbiological urine cultures, and other laboratory values to evaluate treatment effects. Data management follows strict confidentiality and ethical standards, and participation requires informed consent.

Age: 40Years - 70YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.

Age: 18Years +All GendersPhase 3
742 locations