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Can aggressive blood pressure treatment slow aortic valve disease?

NCT ID NCT04613193

Disease control Sponsor: Henrik Wiggers Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether intensive blood pressure lowering slows heart and valve damage in people with asymptomatic moderate to severe aortic valve stenosis. The trial enrolls 60 adults with high blood pressure and a narrowed aortic valve but no symptoms. Half receive standard care and half receive extra medication to reach a strict blood pressure target. The team tracks changes in heart muscle, valve calcium, and cardiovascular events over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intensive blood pressure lowering with antihypertensive medication
What this could lead to
If strict blood pressure control helps, it could offer a low-cost way to delay valve replacement and heart complications for people with asymptomatic aortic valve stenosis.
What could go wrong
This is a small, open-label trial, so results may not hold up in larger studies. Lowering blood pressure aggressively can cause dizziness, falls, or kidney problems in some people.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Mar 2019

Finished

Sep 2026

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

18 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: * Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2 cm2 * Blood pressure: SBP \>= 127 mmHg measured by BP-TRU * LVEF ≥ 50% * Age \> 18 years * Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) for women of childbearing potential. * Negative urine-HCG for women of childbearing potential * Ability to understand the written patient information and to give informed consent. Exclusion Criteria: * Symptoms due to AS * Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16). * Suspicion of secondary hypertension * Participation in other randomized drug study (device studies accepted) * Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography) * Known or suspected ischemic heart disease (coronary angiography with \>70% stenosis in a major epicardial vessel, symptoms or signs of myocardial ischemia, e.g. angina pectoris, wall motion abnormalities). Patients who have previously undergone complete revascularization of major coronary arteries due to angina pectoris are eligible for inclusion. * Significant coronary obstructive lesions detected by baseline Cardiac CT that requires a revascularisation procedure. * eGFR \< 30 ml/min or end-stage renal disease * Other disease, comorbidity or treatment making the subject unsuitable for study participation as judged by the investigator

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis essential hypertension essential hypertension, genetic heart failure hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis Heart failure Hypertension,essential

Contacts and locations

Locations

  • Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99

    Aarhus, Denmark

  • Dept. of Cardiology, Herning Hospital

    Herning, Denmark

  • Dept. of cardiology, Horsens Hospital

    Horsens, Denmark

  • Dept. of cardiology, Randers Hospital

    Randers, Denmark

  • Dept. of cardiology, Viborg Hospital

    Viborg, Denmark

  • Silkeborg Hospital

    Silkeborg, Denmark

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