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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 2

    Valve procedure

    You will receive a transcatheter aortic valve implantation (TAVI)

    This is a procedure to replace your narrowed aortic valve

  3. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

13 criteria

  • 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
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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.

What is already known about the treatment

  • Spironolactone

    A potassium-sparing diuretic medication taken orally in tablet form that belongs to the class of aldosterone antagonists. It works by blocking aldosterone receptors, reducing fluid retention and fibrosis formation in heart tissue. This medication is commonly used to treat high blood pressure, heart failure, and conditions involving excess fluid retention, while in this trial, it's being studied for its potential to reduce myocardial fibrosis in patients with aortic stenosis after TAVI procedure.

  • Dihydralazine

    An antihypertensive medication administered orally that works by directly relaxing smooth muscle in blood vessel walls. It belongs to the vasodilator class of drugs and acts by reducing peripheral vascular resistance, leading to decreased blood pressure. In this clinical trial, it's being studied in combination with spironolactone for its potential synergistic effect in reducing myocardial fibrosis in aortic stenosis patients who undergo TAVI procedure.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510869-42-00Estimated enrolment150 patientsSponsorUniversitaetsmedizin Goettingen

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