Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effect of antifibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burden

This research is focused on adults who have a heart condition called aortic stenosis and also have a significant amount of scarring, known as fibrosis, in their heart muscle. After a procedure called TAVI (Transcatheter Aortic Valve Implantation), which replaces a faulty heart valve, we want to see if certain medicines can reduce this heart scarring. The study will compare two different existing medications, Aldactone and Nepresol, to see which one, if either, is better at reducing this scarring after 12 months. This is an early-stage study (Phase II) aiming to understand if these treatments could help the heart recover better after TAVI and improve long-term outcomes for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsmedizin Goettingen

Enrolment target

150

Start

26 Jul 2024

aortic stenosis patients with high fibrotic burden

What is this study about?

Imagine your heart has a doorway, called the aortic valve, that opens and closes to let blood flow out to your body. In some people, this doorway can become stiff and narrow, making it harder for the heart to pump blood. This condition is called aortic stenosis. Sometimes, when the heart works extra hard because of this narrow valve, it can develop scar tissue, or 'fibrosis'.

Modern medicine has a procedure called TAVI (Transcatheter Aortic Valve Implantation) that can replace this narrow valve. While TAVI fixes the valve problem, we're still learning the best ways to help the heart fully recover, especially if there's a lot of existing scarring. This study is exploring if certain medications, which are already available for other conditions, can help reduce this heart scarring after a TAVI procedure. Less scarring could mean a healthier heart in the long run.

The main goal of this research is to compare two specific medicines, Aldactone and Nepresol. We want to see if either of them can help reduce the amount of scar tissue in the heart over a year after TAVI. We will be using special scans (like detailed MRI scans of the heart) to measure these changes. This information will help us understand if these treatments could improve health outcomes and quality of life for patients with aortic stenosis and heart scarring.

Key takeaways

Study for adults with aortic stenosis and heart scarring.
Investigates if existing medicines can reduce heart scarring after TAVI.
Compares two medicines: Aldactone and Nepresol.
Involves regular check-ups and heart scans for 12 months.
Aims to improve heart recovery and health after valve replacement.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women, who have a specific heart condition. You would need to have been diagnosed with aortic stenosis, which is when the main valve in your heart is narrowed. Importantly, you would also need to have been identified as having a significant amount of scarring in your heart muscle.

To be considered for this study, you would need to have undergone or be scheduled for a procedure called TAVI (Transcatheter Aortic Valve Implantation) to replace your heart valve. The research team will review your medical history and test results to see if you meet all the specific requirements for participation.

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 18 years old or older?
Do you have a diagnosis of aortic stenosis?
Have you been told you have significant scarring in your heart?
Are you having, or have you recently had, a TAVI procedure?
Are you able to attend regular hospital appointments for 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of two study medications: Aldactone or Nepresol, in tablet form, for a specific period after your TAVI procedure. You wouldn't know which one you are getting, and neither would your study doctor, which helps to ensure the results are unbiased. You would need to attend regular follow-up appointments at the hospital over a period of 12 months. These visits will involve health checks, blood tests, and special heart scans, likely MRI scans, to measure changes in your heart's scarring. The total duration of your participation in the study would be approximately 12 months after your TAVI procedure.

Potential risks and benefits

Potential benefits could include receiving a medication that might help reduce scarring in your heart, which could lead to better heart health after your TAVI procedure. However, there's no guarantee this will happen, and one medication might work better than the other, or neither might be effective. As with any medication, there are potential side effects, and the study team will discuss these with you in detail. There will also be some inconvenience due to extra hospital visits and tests. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a procedure where doctors replace a faulty heart valve without open-heart surgery, usually by guiding it through a blood vessel.

What is 'fibrosis' in the heart?

Fibrosis is like scarring in the heart muscle. It can make the heart stiff and less able to pump blood efficiently.

Are the medications new or experimental?

No, both Aldactone and Nepresol are existing medications already approved for other conditions. This study is testing if they can also help with heart scarring after TAVI.

How long will the study last if I join?

If you participate, you would be involved in the study for about 12 months after your TAVI procedure.

Will I know which medication I'm taking?

No, during the study, neither you nor your study doctor will know whether you are receiving Aldactone or Nepresol. This is standard practice in clinical trials to ensure fair results.