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Could a common blood pressure pill protect the heart after valve replacement?

NCT ID NCT07735130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 632 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

aortic valve stenosis Hypertrophy, Left Ventricular

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.