Reduce-MFA-DZHK25


Study information
Reduce-MFA-DZHK25

Recruiting status

Recruiting ongoing

Recruitment start

03/2022

Patients

36

300

Clinical Trials Registration

NCT05230901

Category

Early clinical study

DZHK Funding

EUR 1.796.937

Links

https://reduce-mfa.dzhk.de/

Operative contact
Main study center
Florian Walker, MD
florian.walker@med.uni-goettingen.de

Studienzentren/Kontakt (PDF)

Effect of anti-fibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burden (Reduce-MFA-DZHK25)

Although successfully treating the narrowed aortic valve by catheter-assisted aortic valve implantation (TAVI), patients with a severely scarred heart have a significantly increased risk of dying within the first year after that. To date, patients have not received drug treatments to counteract scarring. The REDUCE-MFA-DZHK25 trial is the first to use two antifibrotic drugs to test whether they can reduce scarring in heart valve patients after TAVI and improve prognosis.

When the aortic valve is narrowed, the heart can no longer pump enough blood to the body, and remodeling processes start in the heart. Healthy heart tissue is replaced by functionless connective tissue (cardiac fibrosis). This results in cardiac insufficiency. In the case of advanced valve stenosis, patients receive a new aortic valve to stop the progressive pathological remodeling processes. In the last ten years, catheter-assisted aortic valve replacement (TAVI) has become established as an alternative to surgery, particularly in older patients. Despite successful surgery, 20 percent of patients die within the first year after TAVI. In a preliminary study, Prof. Miriam Puls and Prof. Elisabeth Zeisberg of the University Medical Center Göttingen investigated the role played by myocardial fibrosis. They found that this apparently cannot entirely be reversed by valve replacement alone. However, the extent of myocardial fibrosis influences how quickly the heart can recover from the valvular defect and plays an important role in the long-term survival of patients and the course of their heart failure.

For the trial, magnetic resonance imaging of the heart (cardiac MRI) is used to identify patients with a severely scarred heart before a planned TAVI. They are then randomly assigned to one of three treatment arms in which they receive either optimal standard therapy or, in addition, different antifibrotic drugs (spironolactone and dihydralazine). After twelve months of treatment with the study medication, the myocardial fibrosis is examined again by MRI to assess the success of the therapy.

Publications

There are no publications available yet.

Principal Investigators

Prof. Dr. Miriam Puls
Universitätsmedizin Göttingen
Prof. Dr. med. Elisabeth Zeisberg
Universitätsmedizin Göttingen / Georg-August-Universität

Press releases and news

New DZHK study to reduce scarring in narrowed heart valves

Despite successful treatment of narrowed aortic valves by catheter-assisted aortic valve...

Study recruitment is available in these cities

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