Angiotensin Receptor Blockers in Aortic Stenosis (ARBAS)
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|ClinicalTrials.gov Identifier: NCT04913870|
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Drug: Angiotensin Receptor Blockers Other: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2025|
Experimental: Angiotensin Receptor Blockers
Angiotensin Receptor Blockers will be given orally once a day for 2 years.
Drug: Angiotensin Receptor Blockers
Angiotensin Receptor Blockers treatment for 2 years.
Placebo Comparator: Placebo
Participants will receive a matched placebo orally once a day for 2 years.
Placebo administration for 2 years.
- Change in the anatomic progression of aortic stenosis [ Time Frame: Baseline, 2 years ]Aortic valve calcification (measured by MDCT)
- Change in peak aortic jet velocity [ Time Frame: Baseline, 2 years ]peak aortic jet velocity (Echocardiography)
- Change in aortic valve area [ Time Frame: Baseline, 2 years ]Aortic valve area (Echocardiography)
- Change in left ventricular (LV) dimension [ Time Frame: Baseline, 2 years ]LV dimension (Echocardiography, MRI)
- Change in left ventricular (LV) mass [ Time Frame: Baseline, 2 years ]LV mass (Echocardiography, MRI)
- Change in left ventricular (LV) fibrosis [ Time Frame: Baseline, 2 years ]LV Fibrosis (MRI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913870
|Contact: Marie-Annick Clavel, PhD||418-656-8711 ext 2678||Marie-Annick.Clavel@criucpq.ulaval.ca|
|Contact: Veronic Tremblay, TM||418-656-8711 ext 3710||Veronic.Tremblay@criucpq.ulaval.ca|
|Québec, Quebec, Canada, G1V 4G5|
|Contact: Marie-Annick Clavel, PhD 418-656-8711 ext 2678 Marie-Annick.Clavel@criucpq.ulaval.ca|
|Contact: Veronic Tremblay 418-656-8711 ext 3710 Veronic.Tremblay@criucpq.ulaval.ca|
|Principal Investigator: Marie-Annick Clavel|
|Odense University Hospital||Recruiting|
|Contact: Ali Mulham, MD +4560677621 Mulham.Ali2@rsyd.dk|
|Principal Investigator: Jordi Sanchez Dahl, MD, PhD|
|Sub-Investigator: Ali Mulham, MD|
|Principal Investigator:||Marie-Annick Clavel, PhD||Institut universitaire de cardiologie et de pneumologie de Québec, University Laval|