RecruitingNAINTERVENTIONAL

Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List

This research is for people with severe heart failure who are on the waiting list for a heart transplant. Heart failure can affect the kidneys, and some heart medicines can also sometimes make kidney problems worse. This study aims to understand this connection better, especially with a medicine called dapagliflozin, which treats heart failure, diabetes, and certain kidney conditions. Researchers will observe how the heart and kidneys are working together over six months by measuring a specific protein in the blood called suPAR. This protein can signal kidney health. The goal is to see if dapagliflozin helps protect the kidneys in people who have advanced heart failure.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

103

Start

29 Aug 2025

Estimated completion

12 Sep 2027

Heart Failure

What is this study about?

If you or someone you know has heart failure, you might know that it means your heart struggles to pump enough blood around your body. This can make you feel tired, breathless, and sometimes cause swelling from too much fluid.

When your heart isn't working as well as it should, it can also put a strain on your kidneys. The kidneys are important for filtering waste from your blood and controlling fluid levels. The connection between the heart and kidneys is really important, and problems in one can affect the other. This is sometimes called 'cardio-renal syndrome'. Medicines used to treat heart failure, like water tablets (diuretics), can sometimes impact the kidneys, too.

This study is looking at a medicine called dapagliflozin. It's already used for heart failure, diabetes, and some kidney problems because it helps the body get rid of extra salt and water, and can improve how your heart and kidneys work. The researchers want to understand more about how dapagliflozin works in people with advanced heart failure who are waiting for a heart transplant, especially regarding how it affects the link between the heart and kidneys. They will measure a particular protein in the blood called suPAR, which can indicate if there's any kidney damage, to track changes over time.

Key takeaways

Targets adults with severe heart failure waiting for a heart transplant.
Investigates dapagliflozin's effects on heart and kidney health.
Uses a blood test (suPAR protein) to monitor kidney function.
Involves 5 visits over 12 months.
Participants must already be taking dapagliflozin.
Aims to improve understanding of this complex heart-kidney connection.

Who may be eligible?

This study is looking for adults aged between 18 and 85 who have severe heart failure (meaning it significantly impacts their daily life) and whose heart only pumps a small amount of blood with each beat. Crucially, participants must already be taking dapagliflozin as part of their heart failure treatment and be on the waiting list for a heart transplant, or actively going through the process to be listed.

There are also some reasons why you wouldn't be able to join. For example, if your heart failure is caused by certain other conditions (like an overactive thyroid or specific heart muscle problems) or if you are already a high-priority patient on the transplant list. You also can't be in the study if your kidney function is very low or rapidly getting worse, if you have type 1 diabetes, or if you've recently had a procedure that might have improved your heart failure symptoms within the last two months. Pregnant or breastfeeding women also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Do you have severe heart failure that greatly affects your daily life (NYHA class 3 or higher)?
Is your heart's pumping ability (LVEF) 35% or less?
Are you already taking dapagliflozin for your heart failure?
Are you currently on the waiting list for a heart transplant, or going through the process to be listed?
Do you *not* have type 1 diabetes?

Answer every question to see your result.

What does participation involve?

If you qualify and choose to take part, the study will involve five visits to the cardiology department at a hospital over a period of 12 months. During these visits, the main activity will be taking a small sample of your blood. These samples will be used to measure the suPAR protein levels, which helps the researchers understand how your kidneys are doing in relation to your heart condition over six months. You will continue to take dapagliflozin as part of your usual heart failure treatment throughout the study.

Potential risks and benefits

By taking part, you would be helping doctors and researchers learn more about how dapagliflozin affects the heart and kidneys in people with advanced heart failure. This could improve care for future patients. While there isn't a direct personal benefit from the blood tests, your ongoing heart failure treatment, including dapagliflozin, will be closely monitored. Risks mainly involve the discomfort of blood draws, such as bruising or minor pain. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Hospice Civil de Lyon - Hôpital Louis PRADEL
Verified postcode
Bron, France· Not yet recruiting
CHU Grenoble
Verified postcode
La Tronche, France· Not yet recruiting
CHU Montpellier
Verified postcode
Montpellier, France· Not yet recruiting
Chu Nantes
Verified postcode
Nantes, France· Not yet recruiting
Aphp Hegp
Verified postcode
Paris, France· Not yet recruiting
CHU Bordeaux
Verified postcode
Pessac, France· Not yet recruiting
CHU Rennes
Verified postcode
Rennes, France· Not yet recruiting
Chu Rouen
Verified postcode
Rouen, France· Not yet recruiting
CHU Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting
CHU de Toulouse
Verified postcode
Toulouse, France· Not yet recruiting
Chru Nancy
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is the main goal of this study?

The study aims to understand how dapagliflozin affects the hearts and kidneys of people with advanced heart failure who are waiting for a transplant.

What is dapagliflozin?

Dapagliflozin is a medication used to treat heart failure, certain kidney diseases, and type 2 diabetes. It helps the body get rid of extra salt and water.

What is suPAR?

SuPAR is a protein found in the blood that researchers will measure to keep an eye on kidney health during the study.

How long will the study last and how many visits are there?

The study lasts for 12 months in total, with 5 visits to the hospital during that time.

Will I receive a new medicine as part of this study?

No, you will continue with your current heart failure treatment, which must already include dapagliflozin.

How to find out more

Guillaume BAUDRY, MD

g.baudry@chru-nancy.fr +33 (0) 383157322 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.