A Phase 1b, Double-blind, Placebo-controlled, Randomised Trial Investigating the Effect of AZD3427 on Renal Perfusion in HFrEF Patients With Renal Impairment Using Positron Emission Tomography (PET)
This study is testing a new medicine, AZD3427, for people who have both heart failure with reduced pumping action and kidney issues. It's a 'Phase 1b' trial, meaning it's an early study to check if the medicine is safe and how it works in the body. Participants will receive either the new medicine or a dummy medicine (placebo) without knowing which one, and doctors will also get a dummy medicine, to ensure fair testing. Using special scans called PET scans, researchers will measure blood flow in the kidneys before and after taking the medicine over 8 days. The main goal is to see if AZD3427 improves blood flow to the kidneys, and they will also closely monitor for any side effects.
At a glance
What is this study about?
This study is investigating a new medication called AZD3427. It's designed for people who have a specific type of heart failure where their heart doesn't pump blood as strongly as it should (this is called 'heart failure with reduced ejection fraction'). These individuals also have kidney problems.
The main idea behind this research is to see if AZD3427 can help improve how much blood flows through the kidneys. When someone has heart failure, their kidneys might not get enough blood, which can make kidney problems worse. Researchers will use a special type of scan called a PET scan to carefully measure this blood flow in specific parts of the kidney.
This is a 'Phase 1b' study, which means it's an early stage of testing. The goal at this stage isn't to cure a condition, but to understand if the medicine is safe, how the body handles it, and if it shows any promising signs of helping. Participants will receive either AZD3427 or a placebo (a dummy medicine that looks the same but has no active drug), and neither the participant nor their doctor will know who is getting what. This helps ensure the results are accurate. They will be closely watched for any side effects and to see if the medicine has the desired effect on kidney blood flow over an 8-day period.
Key takeaways
- This study is testing a new medicine (AZD3427) for heart failure patients with kidney problems.
- It aims to see if the medicine improves blood flow to the kidneys.
- Special scans (PET scans) will be used to measure kidney blood flow.
- Participants will receive either the new medicine or a dummy medicine (placebo).
- It's an early-stage study to check safety and how the medicine works.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Critically, you must have been diagnosed with a specific type of heart failure where your heart isn't pumping blood as strongly as it should. You also need to have some form of kidney problem.
The doctors running the study will check if you meet all the necessary health requirements to make sure it's safe for you to take part. This will involve reviewing your medical history and doing some tests.
- Are you 18 years old or older?
- Do you have heart failure where your heart's pumping action is reduced?
- Do you also have some kind of kidney problem?
- Are you able to attend regular hospital/clinic visits for tests and scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will have several visits to the hospital or clinic over a short period. You will likely take the study medicine (either AZD3427 or the dummy medicine) for 8 days. During your visits, you'll undergo special scans called PET scans to measure blood flow in your kidneys. These scans involve receiving a very small amount of a radioactive substance, which is very safe, to help create detailed images. You will also have regular blood tests, urine tests, heart checks (ECGs), and your vital signs (like blood pressure and heart rate) will be monitored closely. Some IV fluids might be given. The total duration of your active participation in the study, including follow-up checks, will be relatively short, likely a few weeks or months at most.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is 'heart failure with reduced ejection fraction'?
This means your heart muscle isn't pumping blood out to your body as strongly as it should. The 'ejection fraction' is a measurement of how much blood your heart pumps out with each squeeze.
What is a 'PET scan'?
A PET scan is a special type of imaging test that uses a small amount of a safe, radioactive substance to show how your organs and tissues are working, in this case, to measure blood flow in your kidneys.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the effects of the new medicine.
Will I know if I am getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving AZD3427 or the placebo during the main part of the study.
How long will I be in the study?
The main part of the study where you take the medicine and have scans will last 8 days, but there will be initial checks and follow-up visits, so your total participation time will be longer, likely a few weeks to months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.