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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

Tracking Information
First Submitted Date  ICMJE May 3, 2021
First Posted Date  ICMJE June 4, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
Change in the anatomic progression of aortic stenosis [ Time Frame: Baseline, 2 years ]
Aortic valve calcification (measured by MDCT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Angiotensin Receptor Blockers in Aortic Stenosis
Official Title  ICMJE Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE
  • Drug: Angiotensin Receptor Blockers
    Angiotensin Receptor Blockers treatment for 2 years.
  • Other: Placebo
    Placebo administration for 2 years.
Study Arms  ICMJE
  • Experimental: Angiotensin Receptor Blockers
    Angiotensin Receptor Blockers will be given orally once a day for 2 years.
    Intervention: Drug: Angiotensin Receptor Blockers
  • Placebo Comparator: Placebo
    Participants will receive a matched placebo orally once a day for 2 years.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2021)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada,   Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04913870
Other Study ID Numbers  ICMJE 21617
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie-Annick Clavel, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study Sponsor  ICMJE Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborators  ICMJE Odense University Hospital
Investigators  ICMJE
Principal Investigator: Marie-Annick Clavel, PhD Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
PRS Account Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP