Could a common blood pressure pill protect the heart after valve replacement?
NCT ID NCT07735130
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether angiotensin receptor blockers (ARBs), a type of blood pressure medication, can reduce the risk of death or heart failure in people who have had a transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and still have a thickened heart muscle (left ventricular hypertrophy). About 630 participants will receive either an ARB or no ARB for up to 2 years. The goal is to see if blocking certain hormonal signals helps the heart recover after the valve is fixed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an angiotensin receptor blocker (ARB) — candesartan, losartan, or valsartan
- What this could lead to
- If ARBs prove effective, this could become a standard treatment to reduce heart failure and death after TAVR in patients with left ventricular hypertrophy.
- What could go wrong
- This is an open-label trial, so results may be influenced by bias. ARBs can cause side effects like low blood pressure or kidney issues, and the trial's 2-year follow-up may not capture long-term effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 632 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female aged 40 years or older * Symptomatic severe aortic stenosis (AS) with left ventricular hypertrophy (LVH) who successfully underwent transcatheter aortic valve replacement (TAVR) within the prior 30 days, including native-valve or valve-in-valve TAVR \* Severe AS defined by at least one of the following: aortic valve area ≤1.0 cm²; aortic valve area index ≤0.6 cm²/m²; mean pressure gradient ≥40 mmHg; or maximal aortic valve velocity ≥4.0 m/sec \* LVH defined as left ventricular mass index \>115 g/m² in men or \>95 g/m² in women * Successful TAVR (technical success) meeting all VARC-3 criteria: survival; successful access, delivery, and retrieval of the device; correct positioning of a single prosthetic valve in the proper anatomic location; no additional surgery or procedure related to the device (excluding permanent pacemaker implantation) or to major vascular, access-site, or cardiac structural complications; and intended prosthetic valve performance (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) * Left ventricular ejection fraction (LVEF) \>40% before TAVR * Provided written informed consent to participate, either voluntarily or through a legal representative Exclusion Criteria: * Hypotension (systolic blood pressure \<90 mmHg) or hemodynamic instability defined as a need for continuous intravenous vasopressor support at screening * Hyperkalemia (serum potassium \>5.5 mmol/L) * Bilateral renal artery stenosis without stent placement * Allergy, hypersensitivity, or prior intolerance to angiotensin receptor blockers * Pregnancy, breastfeeding, or planning to become pregnant * Estimated life expectancy of less than 2 years * Acute coronary syndrome diagnosed within the past 1 year * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 by the CKD-EPI equation, or currently undergoing renal replacement therapy * Any other medical condition that, in the investigator's judgment, makes participation in the trial inappropriate
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Seoul National University Hospital
Seoul, Seoul, 03080, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A new heart valve without Open-Heart surgery: can it help High-Risk patients?
- Pacemaker signals may unmask a rare heart condition
- Can a single antiplatelet drug beat aspirin after heart valve replacement?
- Massive asian TAVR registry aims to unlock secrets of long-term valve success.
- Brain catcher: new device may prevent stroke during heart procedure