Ongoing Clinical Trials for Cardiac Function Disturbance Postoperative
There are currently 4 clinical trials investigating treatments for complications that can occur after heart surgery. These trials focus on managing bleeding, preventing kidney injury, and reducing inflammation in patients undergoing complex cardiac procedures. The studies are being conducted across several European countries and are testing medications including fibrinogen concentrate, angiotensin II, alkaline phosphatase, and empagliflozin.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Germany
- Italy
- Spain
- Sweden
Study on Fibrinogen Concentrate (FGTW) for Managing Bleeding in Patients Undergoing Complex Cardiac Surgery
This study is investigating a treatment called FGTW, a fibrinogen concentrate, for managing bleeding during and after complex heart surgery. Fibrinogen is a protein that helps blood to clot, and this treatment aims to reduce the need for blood transfusions in patients who have undergone procedures involving cardiopulmonary bypass.
Who can participate: Adults aged 18 or older who are scheduled for complex heart surgery requiring cardiopulmonary bypass. This includes surgeries that are not first-time simple heart bypass, single valve repair or replacement, or atrial septal defect repair. Eligible patients must have a FIBTEM MCF measurement of 10 mm or less during the last 20 minutes of bypass, indicating reduced blood clotting ability. Participants must require a calculated dose of 8 grams or less of the study medication based on their weight and test results. They must also have healthcare insurance, sign an informed consent form, and be willing to follow all study procedures.
Who cannot participate: Patients who are not undergoing complex heart surgery involving cardiopulmonary bypass, those not experiencing bleeding during surgery, individuals outside the specified age range, those not meeting gender requirements, and people considered part of vulnerable populations requiring special protection.
Main focus: The trial aims to evaluate whether FGTW can decrease the need for blood transfusions within the first 24 hours after surgery when used alongside standard care. Researchers will monitor the amount of blood products needed, blood drainage volume, length of hospital stay, and any complications. The treatment is delivered through intravenous infusion directly into the bloodstream during surgery.
Investigational drug: FGTW is a fibrinogen concentrate that works by increasing fibrinogen levels in the blood, enhancing the body’s ability to form clots and stop bleeding. It is classified as a hemostatic agent.
Study on Reducing Acute Kidney Injury After Heart Surgery Using Angiotensin II or Noradrenaline for Patients with Low Blood Pressure
This trial focuses on preventing acute kidney injury, a condition where the kidneys suddenly stop working properly, in patients after heart surgery. The study compares two treatments for managing low blood pressure: Angiotensin II and Noradrenaline.
Who can participate: Adults aged 18 or older who have undergone cardiac surgery using cardiopulmonary bypass, including coronary artery bypass grafting, valve surgery, or a combination of both. Eligible patients must have an elevated risk of acute kidney injury, determined by a score of 1.5 or higher based on factors such as hemoglobin levels below 130 g/L, creatinine levels above 1.1 mg/dL, age over 70, NYHA class 4 heart failure, or body mass index over 30. Written informed consent is required.
Who cannot participate: Patients who have recently had acute kidney injury, those not within the specified age range, individuals not part of the designated clinical trial group, and those considered part of vulnerable populations at higher risk of harm.
Main focus: The study aims to determine if using Angiotensin II can reduce the occurrence of moderate or severe acute kidney injury within 72 hours after cardiac surgery. Researchers will compare this with Noradrenaline, which is commonly used to increase blood pressure. Both medications are delivered through intravenous infusion and will be monitored for up to three days. Additional outcomes include mortality rates, need for dialysis within 90 days, and long-term kidney function changes.
Investigational drugs: Angiotensin II helps regulate blood pressure by narrowing blood vessels. Noradrenaline works by stimulating receptors that also cause blood vessels to narrow and blood pressure to rise. Both are vasopressors used to manage low blood pressure during and after surgery.
Study on Alkaline Phosphatase to Prevent Inflammation and Kidney Injury in Patients Undergoing Open-Heart Surgery
This study investigates RESCAP iv, which contains alkaline phosphatase derived from bovine sources, for reducing complications related to systemic inflammation that can occur when using a heart-lung machine during open-heart surgery.
Who can participate: Adults over 21 years old undergoing cardiac surgery with planned use of a heart-lung machine. Eligible patients must have a EuroSCORE II of 3 or higher, which measures surgery risk. Participants must be able to understand and agree to the study requirements and must sign written informed consent.
Who cannot participate: Patients not experiencing systemic inflammation as a side effect of the heart-lung machine, those outside the specified age range, and individuals considered part of vulnerable populations requiring special protection.
Main focus: The trial aims to determine if RESCAP iv can help patients reach stability more quickly in the intensive care unit after surgery. The study will monitor how quickly patients recover over 12 days using a severity scoring system. A key secondary outcome is whether the treatment can reduce the occurrence and severity of acute kidney injury within 30 and 90 days after surgery. Participants receive either RESCAP iv or a placebo through intravenous injection or infusion.
Investigational drug: RESCAP iv contains alkaline phosphatase, an enzyme therapy designed to reduce inflammation and protect against tissue damage. It works by decreasing oxidative stress-related complications during and after heart-lung machine use.
Study on Preventing Acute Kidney Injury After Heart Surgery Using Empagliflozin in Patients Undergoing Elective Cardiac Surgery
This trial studies empagliflozin, typically used to control blood sugar in diabetes, for preventing acute kidney injury in patients undergoing planned heart surgery with a heart-lung machine.
Who can participate: Adults aged 18 or older scheduled for elective cardiac surgery involving extracorporeal circulation, where a machine temporarily takes over heart and lung function. Both men and women can participate. Eligible patients must understand the study’s purpose and provide written informed consent.
Who cannot participate: Patients not undergoing elective cardiac surgery with extracorporeal circulation, those outside the specified age range, individuals in vulnerable populations, those with medical conditions or taking medications that could interfere with the study, pregnant or breastfeeding women, patients with a history of allergic reactions to the study drug or similar medications, and those participating in another clinical trial.
Main focus: The study aims to determine if taking empagliflozin once daily around the time of surgery can reduce the chances of developing acute kidney injury. Participants will take either empagliflozin or a placebo for a period before and after surgery. Researchers will monitor kidney function and overall health for up to 90 days following surgery, checking the estimated glomerular filtration rate to measure how well the kidneys are filtering.
Investigational drug: Empagliflozin is a film-coated tablet taken orally at a 10 mg dose once daily. It works by inhibiting sodium-glucose cotransporter 2 in the kidneys, which reduces glucose reabsorption and may have protective effects on the kidneys during surgery. It is classified as an SGLT2 inhibitor.
Summary
The four ongoing clinical trials address critical complications that can arise after heart surgery, focusing on three main areas: bleeding management, kidney injury prevention, and inflammation reduction. The studies are distributed across multiple European countries, with Germany participating in two trials and Spain also hosting two studies. Other participating countries include Austria, Belgium, Czechia, Italy, and Sweden.
A notable trend is the emphasis on preventing acute kidney injury, with three of the four trials targeting this complication through different approaches. Two trials specifically compare different blood pressure management strategies and investigate protective medications, while one explores inflammation reduction as a pathway to kidney protection. The fourth trial addresses bleeding complications during complex cardiac procedures.
The investigational treatments represent diverse pharmacological approaches, including clotting factors, enzyme therapies, blood pressure regulators, and medications originally developed for diabetes management. All trials involve patients undergoing cardiac surgery with cardiopulmonary bypass or extracorporeal circulation, highlighting the particular risks associated with these procedures. The studies are expected to continue through 2026 and 2027, with results potentially informing improved care protocols for cardiac surgery patients.
