Study of Spironolactone and Dihydralazine for reducing heart muscle scarring in patients with severe aortic valve narrowing after valve replacement procedure

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What is this study about?

This study focuses on patients with aortic stenosis, a condition where the heart’s aortic valve narrows, making it harder for blood to flow from the heart to the rest of the body. These patients will undergo a procedure called transcatheter aortic valve implantation (TAVI), which involves replacing the narrowed valve. The study specifically looks at patients who have high levels of heart muscle scarring (fibrosis).

The research aims to determine if medications that fight tissue scarring can help reduce heart muscle scarring after the valve replacement procedure. The study will use two medications: spironolactone and dihydralazine. Some patients will receive spironolactone alone, some will receive both medications together, and others will receive standard care without these additional medications.

The study will last 12 months, during which patients will take their assigned medications daily. To measure the amount of heart muscle scarring, patients will undergo cardiac magnetic resonance imaging (CMR) before their valve replacement procedure and again one year later. This imaging test uses a special dye called gadolinium to show areas of scarring in the heart muscle.

1 Initial medical imaging

You will undergo a cardiac magnetic resonance imaging (CMR) scan before the valve procedure to assess your heart condition

During the scan, a contrast agent will be used to examine the heart tissue in detail

2 Valve procedure

You will receive a transcatheter aortic valve implantation (TAVI)

This is a procedure to replace your narrowed aortic valve

3 Treatment assignment

You will be assigned to one of three treatment groups:

Group 1: Standard care with no additional medication

Group 2: Standard care plus spironolactone tablets (25 mg)

Group 3: Standard care plus spironolactone tablets (25 mg) and dihydralazine tablets (25 mg)

4 Treatment period

The treatment period will last for 12 months

If assigned to medication groups, you will take the prescribed tablets orally according to your treatment plan

5 Final assessment

After 12 months, you will undergo another cardiac magnetic resonance imaging (CMR) scan

This scan will assess changes in your heart tissue compared to the first scan

Who Can Join the Study?

  • Age 60 years or older
  • Must have been diagnosed with severe symptomatic aortic stenosis (a condition where the heart’s aortic valve is narrowed and causing symptoms)
  • Must be scheduled for TAVI (Transcatheter Aortic Valve Implantation – a minimally invasive procedure to replace the narrowed aortic valve)
  • Must be able to provide written informed consent (formal agreement to participate in the study after understanding all aspects of participation)
  • Can be either male or female

Who Cannot Join the Study?

  • History of allergic reactions to spironolactone (a medication used to treat fluid retention) or dihydralazine (a blood pressure medication)
  • Severe kidney problems (as indicated by estimated glomerular filtration rate below 30 mL/min)
  • High blood potassium levels (above 5.0 mmol/L)
  • Inability to undergo cardiac magnetic resonance imaging (CMR) due to medical devices or claustrophobia
  • Contraindications to gadolinium contrast agents (substances used during imaging)
  • Pregnancy or breastfeeding
  • Currently participating in another clinical trial
  • Mental conditions that prevent giving informed consent
  • Life expectancy less than one year
  • Severe liver disease
  • Uncontrolled high blood pressure (systolic blood pressure above 160 mmHg)
  • Known drug or alcohol abuse
  • Unable to follow study procedures or attend follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Herzzentrum Leipzig GmbH Leipzig Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen Munich Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Utytcfyjdy Mdwuuya Crwpxu Hdlhuijugcsgtvzju Hamburg Germany
Gjlqqz Uxrowrrebd Fuzfangqe Frankfurt Germany
Kgvtvxgp drc Udtpviiganfe Mzslhpbd Asu Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.03.2022

Trial locations

Investigated drugs:

Spironolactone is a medication that helps reduce fluid retention and works as an anti-fibrotic agent. It is commonly used to treat heart conditions and can help decrease scarring (fibrosis) in heart tissue. In this trial, it is being studied for its potential to reduce heart tissue scarring after a valve procedure.

Dihydralazine is a blood pressure-lowering medication that relaxes blood vessels. In this trial, it is being studied in combination with spironolactone to see if it can enhance the anti-fibrotic effects and help reduce heart tissue scarring more effectively.

TAVI (Transcatheter Aortic Valve Implantation) is a medical procedure where a new heart valve is inserted through a small tube in your blood vessels to replace a damaged aortic valve. While this is not a medication, it is an important part of the treatment that all patients in the trial will receive.

Investigated diseases:

Aortic Stenosis – A condition where the aortic valve in the heart becomes narrow and stiff due to calcium buildup or scarring. This narrowing restricts blood flow from the heart to the aorta, forcing the heart to work harder to pump blood. Over time, this extra workload causes the heart muscle to thicken and may lead to the development of fibrotic tissue in the heart muscle. The condition typically develops gradually over many years, and the heart changes its structure to compensate for the narrowed valve. In some cases, significant scarring (fibrosis) can develop in the heart muscle tissue as a response to the increased strain.

Trial ID:
2024-510869-42-00
Trial Phase:
Therapeutic exploratory (Phase II)

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