Aortic StenosisPhase 4ARBASNCT04913870
Angiotensin Receptor Blockers in Aortic Stenosis
A Phase 4 study testing Angiotensin Receptor Blockers in people with Aortic Stenosis and Aortic Valve Stenosis, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 2 sites in 2 countries.
Trial summary
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Aortic Stenosis, Aortic Valve Stenosis
- What is being tested?
- Angiotensin Receptor Blockers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2020to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)
- Normal left ventricular ejection fraction (i.e. ≥50%)
- Systolic blood pressure >110 mmHg
- Diastolic blood pressure >70 mmHg
Who cannot join
- More than mild aortic or mitral regurgitation, or mitral stenosis
- Current use or documented indication for renin-angiotensin system medication or Aliskiren
- Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
- Alzheimer, dementia or known non-compliant patient
- Renal dysfunction (glomerular filtration rate <30ml/min/1.73m2)
- Chronic hyperkalemia
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- Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
- Newly diagnosed (<2 months) or poorly controlled diabetes
- Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months)
- Pregnant or lactating women
- Patients unable to read, understand or sign research consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
CRIUCPQ
Québec, Quebec, G1V 4G5
Marie-Annick Clavel, PhD, 418-656-8711 ext. 2678, Marie-Annick.Clavel@criucpq.ulaval.ca
418-656-8711 ext. 3868
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense
Ali Mulham, MD, +4560677621, Mulham.Ali2@rsyd.dk
Jordi Sanchez Dahl, MD, PhD
About this study
Official title: Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.
Read the detailed description
Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.
Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Being tested
- Angiotensin Receptor Blockers, Placebo
- Keywords
- Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Ventricular Remodeling, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin Receptor BlockersDrug
Angiotensin Receptor Blockers treatment for 2 years.
PlaceboOther
Placebo administration for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin Receptor Blockers | Experimental | Angiotensin Receptor Blockers will be given orally once a day for 2 years. Receives: Drug: Angiotensin Receptor Blockers |
| Placebo | Placebo comparator | Participants will receive a matched placebo orally once a day for 2 years. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the anatomic progression of aortic stenosis
Aortic valve calcification (measured by MDCT)
Measured: Baseline, 2 years
Secondary outcomes (5)
Change in peak aortic jet velocity
peak aortic jet velocity (Echocardiography)
Measured: Baseline, 2 years
Change in aortic valve area
Aortic valve area (Echocardiography)
Measured: Baseline, 2 years
Change in left ventricular (LV) dimension
LV dimension (Echocardiography, MRI)
Measured: Baseline, 2 years
Change in left ventricular (LV) mass
LV mass (Echocardiography, MRI)
Measured: Baseline, 2 years
Change in left ventricular (LV) fibrosis
LV Fibrosis (MRI)
Measured: Baseline, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Feb 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Marie-Annick Clavel, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Marie-Annick Clavel, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913870
- Sponsor's protocol ID
- 21617
- Acronym
- ARBAS
- Status last verified
- Mar 2024
- First submitted
- 3 May 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali M, Frederiksen PH, Moller JE, Mogensen NSB, Chemnitz A, Haujir A, Poulsen MK, Ovrehus KA, Pibarot P, Pellikka PA, Clavel MA, Dahl JS. Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Circ Heart Fail. 2026 Apr;19(4):e012809. doi: 10.1161/CIRCHEARTFAILURE.125.012809. Epub 2026 Feb 23.
PubMed 41730521
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04913870
- Acronym / sponsor ID
- ARBAS / 21617
- Conditions
- Aortic Stenosis, Aortic Valve Stenosis
- Keywords
- Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.
Detailed description
Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.
Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiotensin Receptor Blockers | Experimental | Drug: Angiotensin Receptor BlockersAngiotensin Receptor Blockers will be given orally once a day for 2 years. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a matched placebo orally once a day for 2 years. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)
- Normal left ventricular ejection fraction (i.e. ≥50%)
- Systolic blood pressure >110 mmHg
- Diastolic blood pressure >70 mmHg
Key exclusion criteria (11 listed)
- More than mild aortic or mitral regurgitation, or mitral stenosis
- Current use or documented indication for renin-angiotensin system medication or Aliskiren
- Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
- Alzheimer, dementia or known non-compliant patient
- Renal dysfunction (glomerular filtration rate <30ml/min/1.73m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin Receptor BlockersAngiotensin Receptor Blockers treatment for 2 years. | Drug | Angiotensin Receptor Blockers |
| PlaceboPlacebo administration for 2 years. | Other | Placebo |
Primary outcome
Change in the anatomic progression of aortic stenosis
Time frame: Baseline, 2 years
Aortic valve calcification (measured by MDCT)
5 secondary outcomes
Change in peak aortic jet velocity
Time frame: Baseline, 2 years
Change in aortic valve area
Time frame: Baseline, 2 years
Change in left ventricular (LV) dimension
Time frame: Baseline, 2 years
Change in left ventricular (LV) mass
Time frame: Baseline, 2 years
Change in left ventricular (LV) fibrosis
Time frame: Baseline, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 41730521Ali M, Frederiksen PH, Moller JE, Mogensen NSB, Chemnitz A, Haujir A, Poulsen MK, Ovrehus KA, Pibarot P, Pellikka PA, Clavel MA, Dahl JS. Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Circ Heart Fail. 2026 Apr;19(4):e012809. doi: 10.1161/CIRCHEARTFAILURE.125.012809. Epub 2026 Feb 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Annick Clavel, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin Receptor Blockers in people with Aortic Stenosis and Aortic Valve Stenosis, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Annick Clavel, PhD (418-656-8711 ext. 2678, Marie-Annick.Clavel@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the anatomic progression of aortic stenosis (time frame: Baseline, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.