In short
Four clinical trials are currently investigating different aspects of heart transplantation care, including organ preservation methods in children, medication interactions after transplant, cholesterol management, and kidney protection. These studies are taking place across several European countries including Germany, the Netherlands, Norway, Sweden, and Czechia.
Clinical trial locations
- Czechia
- Germany
- Netherlands
- Norway
- Sweden
Study comparing Custodiol-N and Custodiol organ preservation solutions for heart transplantation in children
This trial is comparing two organ preservation solutions used during pediatric transplantation procedures. The solutions being tested are Custodiol and Custodiol-N, both designed to protect donor hearts during transportation and before transplantation.
Who can participate: Children from birth to 17 years old who are waiting for their first heart transplant are eligible. Participants must be officially registered on the transplant waiting list, and either the child or their legal guardians must be able to understand the study and provide written consent. The donor organ must meet standard donation criteria.
Who cannot participate: The trial excludes children who have had previous transplants, those with active infections that could affect surgery outcomes, severe allergic reactions to preservation medications, or severe lung problems that make transplantation too risky. Children whose families cannot attend required follow-up visits for 3 months after surgery or who have known allergies to Custodiol solutions are also excluded.
Study focus: The main goal is to evaluate the safety of both preservation solutions in children receiving their first heart transplant. Researchers will monitor vital signs, perform blood tests to measure heart-related proteins, and use ultrasound to assess how well the transplanted heart is working. The study tracks various outcomes including length of intensive care stay, need for heart support medications, and overall heart function.
Investigational treatments: Custodiol is a standard preservation solution containing electrolytes and buffer systems that protect heart tissue during transport. Custodiol-N is a newer version with enhanced protective compounds designed to provide better protection against tissue damage. Both are administered by perfusion of the donor organ.
Study on How Pantoprazole Affects the Absorption of Mycophenolate Mofetil in Post-Transplant Patients
This study examines how pantoprazole, a stomach acid-reducing medication, affects the absorption of mycophenolate mofetil, a medication used to prevent organ rejection after transplantation.
Who can participate: Healthy male volunteers between 18 and 55 years old with body weight over 50 kg and a Body Mass Index between 18.5 and 30 kg/m² can join. Participants must have normal vital signs including systolic blood pressure between 90-149 mmHg, diastolic blood pressure between 50-89 mmHg, and heart rate between 50-90 beats per minute. Normal laboratory test results are required, though minor deviations may be acceptable if deemed insignificant by study doctors.
Who cannot participate: Individuals who are not post-transplant recipients, females, people under 18 or over 65 years old, and members of vulnerable populations are excluded from participation.
Study focus: The trial aims to understand whether taking pantoprazole alongside mycophenolate mofetil changes how the body absorbs the immunosuppressant medication. Researchers will compare different formulations of mycophenolate mofetil, including generic and brand-name versions, to determine if they are bioequivalent when taken with pantoprazole. Regular monitoring assesses medication concentration in the blood over time.
Investigational treatments: Pantoprazole is administered as a 40 mg gastro-resistant tablet that reduces stomach acid production. Mycophenolate mofetil is given as a 500 mg film-coated tablet that suppresses the immune system by inhibiting enzymes crucial for immune cell growth. Both medications are taken orally.
Study on Alirocumab for Preventing Heart Vessel Disease in Recent Heart Transplant Patients
This trial investigates whether alirocumab can help prevent cardiac allograft vasculopathy, a condition where blood vessels in the transplanted heart become thick and narrow, in recent transplant recipients.
Who can participate: Adults 18 years or older who received a heart transplant 3-8 weeks before the baseline study visit are eligible. Participants must be willing to join the study, able to understand and follow study procedures for its entire duration, and provide written informed consent either personally or through a legal representative.
Who cannot participate: Patients who have not had a recent heart transplant, those not experiencing cardiac allograft vasculopathy, individuals not taking atorvastatin 10 mg daily as standard treatment, those outside the specified age range, and members of vulnerable populations are excluded.
Study focus: The primary objective is to evaluate how effective alirocumab is in lowering LDL-cholesterol levels in recent transplant recipients. The study also examines the medication's impact on other aspects of the lipid profile, including total cholesterol, HDL cholesterol, various apolipoproteins, and triglyceride levels. Participants will be monitored over 12 months with regular assessments of cholesterol levels and other health parameters.
Investigational treatments: Alirocumab is administered as an injection under the skin, typically every two weeks. It works by blocking a protein called PCSK9, which helps the liver remove more LDL cholesterol from the blood. Participants also continue taking atorvastatin 10 mg daily as background therapy, which reduces the amount of cholesterol made by the liver.
Study on Dapagliflozin for Kidney Protection in Heart Transplant Patients
This study evaluates whether dapagliflozin can help protect kidney function in individuals who have undergone transplantation and are experiencing kidney problems.
Who can participate: Adults 18 years or older who received a heart transplant at least one year prior can join. Participants must have an estimated glomerular filtration rate of at least 25 ml/min/1.73 m², as measured by the MDRD formula, and must have provided informed consent according to ethical research guidelines. The study doctor must consider them suitable for random assignment to either dapagliflozin or placebo.
Who cannot participate: Patients with severe kidney failure where kidneys are not working adequately cannot participate. The trial specifically focuses on those with declining but not completely failed kidney function.
Study focus: The main goal is to assess how dapagliflozin affects kidney function over 12 months. The primary endpoint measures the change in estimated glomerular filtration rate from two weeks to the end of treatment. Secondary outcomes include changes in body weight, the albumin-to-creatinine ratio in urine, and blood sugar control in patients with diabetes. The study also examines body composition changes and various biomarkers of kidney damage.
Investigational treatments: Dapagliflozin is administered orally as a 10 mg film-coated tablet. It works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2, which helps reduce blood sugar levels and may have protective effects on kidney function. While typically used for diabetes management, this study explores its potential benefits for kidney protection in transplant recipients.
Summary
The four ongoing clinical trials address diverse aspects of transplantation care across the patient journey. One trial focuses specifically on pediatric patients in Germany, comparing preservation solutions used during the transplantation procedure itself. The remaining three studies address post-transplant complications and medication management in adult recipients.
Geographically, the Netherlands hosts the most trials with two studies, while research is also being conducted in Germany, Czechia, Norway, and Sweden. One trial spans multiple Scandinavian countries, reflecting international collaboration in transplant research.
The studies investigate different therapeutic areas: organ preservation during transplantation, medication interactions affecting immunosuppressant absorption, prevention of blood vessel disease through cholesterol management, and kidney function protection. This variety demonstrates the complex, ongoing medical needs of transplant recipients throughout their treatment journey.
Several trials examine medications originally developed for other conditions, such as dapagliflozin for diabetes and alirocumab for cholesterol management, exploring their potential benefits in the transplant population. This approach of repurposing existing medications may offer new treatment options for preventing common post-transplant complications.
