Study of Ataciguat to Slow Progression of Moderate Calcific Aortic Valve Stenosis in Adults

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What is this study about?

The study focuses on individuals with Moderate Calcific Aortic Valve Stenosis, a condition where calcium deposits cause the aortic valve to become stiff and restrict blood flow from the heart. The medication being evaluated is Ataciguat, an oral capsule taken daily, and a matching inactive tablet is used for comparison.

The purpose is to determine whether the study drug can slow the narrowing of the valve and improve exercise capacity. Participants will remain in the trial for about one year, during which routine visits will include an ultrasound of the heart called an echocardiogram to measure how wide the valve opens, and a breathing test known as CPET that measures the maximum amount of oxygen the body can use during exercise. Occasionally, a scan using CT will be performed to assess calcium buildup, and any decisions about future valve replacement procedures such as TAVR or SAVR will be recorded.

1 randomization

upon joining the study, assignment to either ataciguat or placebo is made using a double‑blind randomization process.

the participant and study staff remain unaware of which treatment is received.

2 start of study medication

the assigned medication is taken by mouth as a capsule.

each capsule contains 200 mg of ataciguat (or a matching placebo).

the medication is taken according to the study schedule for a total period of 48 weeks.

3 baseline assessments

an echocardiogram is performed to measure the aortic valve area (AVA).

a cardiopulmonary exercise test (cpet) is done to determine peak vo2.

a non‑contrast computed tomography (ct) scan is obtained to calculate the aortic valve calcium (avc) score.

4 regular monitoring visits

throughout the 48‑week period, clinic visits are scheduled to check safety, record any side effects, and ensure proper medication use.

routine blood tests and symptom questionnaires may be completed at each visit.

5 week 48 final assessments

a repeat echocardiogram is performed to evaluate change in AVA from baseline.

a repeat cpet measures the change in peak vo2 from baseline.

a repeat non‑contrast ct scan assesses the change in the avc score.

6 completion of study medication

after the week 48 assessments, the study medication course ends.

the participant ceases taking the study capsule and concludes involvement in the trial.

Who Can Join the Study?

Be at least 50 years old and able to give consent, regardless of gender.
Have moderate calcific aortic valve stenosis (CAVS), which means the heart’s aortic valve is narrowed but not severe. This is shown by an aortic valve area (AVA) between 1.0 cm² and 1.5 cm², and by a calcium amount measured on a special scan (non‑contrast CT) called an AVC score that is between 600 and 1,200 Agatston units for women or between 600 and 2,000 Agatston units for men.
Have a left ventricular ejection fraction (EF) of 45% or higher, which means the main pumping chamber of the heart is working well enough.
If you are taking beta blockers (medicines that lower heart rate and blood pressure), the dose must have been unchanged for at least 90 days before the screening visit and should stay the same during the study.
Meet any other requirements that are listed in the detailed study protocol.

Who Cannot Join the Study?

Anyone who has already had or is planning to have an aortic valve replacement, repair, surgery, or other valve procedure within the next six months cannot join the study. (aortic valve replacement is surgery to replace the heart’s aortic valve.)
People with moderate to severe narrowing (stenosis) or leaking (regurgitation) of the mitral valve or aortic valve are excluded. This includes conditions called mitral stenosis, mitral regurgitation, and aortic regurgitation.
Anyone who has a known or suspected birth‑related (congenital) problem with the aortic valve, such as a bicuspid aortic valve (a valve with two leaflets instead of three), cannot participate.
People who have heart‑failure symptoms classified as New York Heart Association (NYHA) Class III or Class IV are not eligible. This means they feel short‑of‑breath with ordinary activity (Class III) or even at rest (Class IV).
If the main cause of a person’s heart failure is something other than an aortic valve problem, they are excluded.
Anyone with coronary artery disease (blocked heart arteries) or who plans to have a coronary stent placed (a small tube to keep an artery open) cannot join.
People with a prolonged heart‑rate‑corrected QT interval (QTcF) of 480 milliseconds or more, or who have risk factors for a dangerous rhythm called torsades de pointes, are excluded. Risk factors include low potassium (hypokalemia), a family history of long QT syndrome, or taking medicines that lengthen the QT/QTc interval, as well as an abnormal electrocardiogram (ECG) or ongoing persistent atrial fibrillation (atrial fibrillation is an irregular heartbeat).
For the parts of the study that require a maximal exercise test (CPET), anyone with a medical or physical condition that could prevent completing the test is excluded. Examples are lung disease (pulmonary disease), joint, leg, hip, or back problems that limit activity, or any other absolute reason not to perform the test.
Any additional exclusion reasons listed in the study protocol also apply.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Medical University Of Graz	Graz	Austria
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Hospor Hospitais Portugueses S.A.	Setubal	Portugal
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Centrum Medyczne Zdrowa	Cracow	Poland
Nemocnice Ceske Budejovice a.s.	Ceske Budejovice	Czechia
Fakultni Nemocnice Brno	Brno	Czechia
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vojenska Nemocnice Brno	Brno-Zidenice	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Santa Sp. z o.o.	Lodz	Poland
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
Kardio Brynow Sp. z o.o.	Katowice	Poland
Hekkxfej Vaay dsxpffem	Barcelona	Spain
Almwuyk Skd z oddq	Poznan	Poland
Hjmvbtml Udggcgcyrqrpf di A Ciiwya	A Coruna Galicia	Spain
Antmleip Utugnuuwpl Hymyrfcl	Lorenskog	Norway
Ulygjtcewpxlag Cmneewl Kvlhgmjtx	Gdansk	Poland
Cpwlhcrr Hcxtarwsqndq Uemfzhwbwfbnb Dq Vlqm	Vigo	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.10.2026
Czechia	Not yet recruiting	01.10.2026
France	Not yet recruiting	01.10.2026
Norway	Not yet recruiting	01.10.2026
Poland	Not yet recruiting	01.10.2026
Portugal	Not yet recruiting	01.10.2026
Spain	Not yet recruiting	01.10.2026

Trial locations

Ataciguat is an oral capsule taken by mouth that is being tested in this study. Researchers are looking to see if it can slow down the worsening of the aortic valve in people who have moderate calcific aortic valve stenosis. The trial will also check whether the medication can improve the participants’ ability to exercise, measured by the highest amount of oxygen their bodies can use during a workout (called peak VO₂). This medication is the only active treatment being evaluated; any placebo pills are not described here.

Calcific Aortic Valve Stenosis – Calcific Aortic Valve Stenosis is a condition where calcium builds up on the aortic valve, making it harder for the valve to open fully. As the valve narrows, the heart must work harder to pump blood to the rest of the body. Over time the opening of the valve becomes smaller, which can lower the amount of blood that leaves the heart with each beat. This gradual narrowing often leads to reduced ability to perform physical activities and may cause shortness of breath during exertion. The disease typically progresses slowly, with the valve area decreasing over months to years.

Trial ID:

2025-522176-86-01

Protocol code:

ATA-301

NCT ID:

NCT07001800

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Ataciguat to Slow Progression of Moderate Calcific Aortic Valve Stenosis in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?