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Angiotensin Receptor Blockers in Aortic Stenosis (ARBAS)

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Angiotensin Receptor Blockers
Placebo
Sponsored by
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CRIUCPQRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angiotensin Receptor Blockers

Placebo

Arm Description

Angiotensin Receptor Blockers will be given orally once a day for 2 years.

Participants will receive a matched placebo orally once a day for 2 years.

Outcomes

Primary Outcome Measures

Change in the anatomic progression of aortic stenosis
Aortic valve calcification (measured by MDCT)

Secondary Outcome Measures

Change in peak aortic jet velocity
peak aortic jet velocity (Echocardiography)
Change in aortic valve area
Aortic valve area (Echocardiography)
Change in left ventricular (LV) dimension
LV dimension (Echocardiography, MRI)
Change in left ventricular (LV) mass
LV mass (Echocardiography, MRI)
Change in left ventricular (LV) fibrosis
LV Fibrosis (MRI)

Full Information

First Posted
May 3, 2021
Last Updated
November 12, 2022
Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04913870
Brief Title
Angiotensin Receptor Blockers in Aortic Stenosis
Acronym
ARBAS
Official Title
Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborators
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Angiotensin II Receptor Blockers, Left ventricular remodeling, Valvular heart disease, Aortic stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angiotensin Receptor Blockers
Arm Type
Experimental
Arm Description
Angiotensin Receptor Blockers will be given orally once a day for 2 years.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a matched placebo orally once a day for 2 years.
Intervention Type
Drug
Intervention Name(s)
Angiotensin Receptor Blockers
Intervention Description
Angiotensin Receptor Blockers treatment for 2 years.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo administration for 2 years.
Primary Outcome Measure Information:
Title
Change in the anatomic progression of aortic stenosis
Description
Aortic valve calcification (measured by MDCT)
Time Frame
Baseline, 2 years
Secondary Outcome Measure Information:
Title
Change in peak aortic jet velocity
Description
peak aortic jet velocity (Echocardiography)
Time Frame
Baseline, 2 years
Title
Change in aortic valve area
Description
Aortic valve area (Echocardiography)
Time Frame
Baseline, 2 years
Title
Change in left ventricular (LV) dimension
Description
LV dimension (Echocardiography, MRI)
Time Frame
Baseline, 2 years
Title
Change in left ventricular (LV) mass
Description
LV mass (Echocardiography, MRI)
Time Frame
Baseline, 2 years
Title
Change in left ventricular (LV) fibrosis
Description
LV Fibrosis (MRI)
Time Frame
Baseline, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Annick Clavel, PhD
Phone
418-656-8711
Ext
2678
Email
Marie-Annick.Clavel@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Annick Clavel, PhD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRIUCPQ
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Annick Clavel, PhD
Phone
418-656-8711
Ext
2678
Email
Marie-Annick.Clavel@criucpq.ulaval.ca
Phone
418-656-8711
Ext
3868
First Name & Middle Initial & Last Name & Degree
Marie-Annick Clavel
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Mulham, MD
Phone
+4560677621
Email
Mulham.Ali2@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Jordi Sanchez Dahl, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ali Mulham, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Angiotensin Receptor Blockers in Aortic Stenosis

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