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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
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Marie-Annick Clavel, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Brief Summary:
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Drug: Angiotensin Receptor Blockers Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo
Placebo administration for 2 years.




Primary Outcome Measures :
  1. Change in the anatomic progression of aortic stenosis [ Time Frame: Baseline, 2 years ]
    Aortic valve calcification (measured by MDCT)


Secondary Outcome Measures :
  1. Change in peak aortic jet velocity [ Time Frame: Baseline, 2 years ]
    peak aortic jet velocity (Echocardiography)

  2. Change in aortic valve area [ Time Frame: Baseline, 2 years ]
    Aortic valve area (Echocardiography)

  3. Change in left ventricular (LV) dimension [ Time Frame: Baseline, 2 years ]
    LV dimension (Echocardiography, MRI)

  4. Change in left ventricular (LV) mass [ Time Frame: Baseline, 2 years ]
    LV mass (Echocardiography, MRI)

  5. Change in left ventricular (LV) fibrosis [ Time Frame: Baseline, 2 years ]
    LV Fibrosis (MRI)



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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Canada, Quebec
CRIUCPQ Recruiting
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         
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Ali Mulham, MD    +4560677621    Mulham.Ali2@rsyd.dk   
Principal Investigator: Jordi Sanchez Dahl, MD, PhD         
Sub-Investigator: Ali Mulham, MD         
Sponsors and Collaborators
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Odense University Hospital
Investigators
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Principal Investigator: Marie-Annick Clavel, PhD Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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Responsible Party: Marie-Annick Clavel, Associate Professor, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
ClinicalTrials.gov Identifier: NCT04913870    
Other Study ID Numbers: 21617
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie-Annick Clavel, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval:
Angiotensin II Receptor Blockers
Left ventricular remodeling
Valvular heart disease
Aortic stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action