NCT04913870

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
9mo left

Started Feb 2020

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2020Feb 2027

Study Start

First participant enrolled

February 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 20, 2024

Status Verified

March 1, 2024

Enrollment Period

7 years

First QC Date

May 3, 2021

Last Update Submit

December 18, 2024

Conditions

Aortic StenosisAortic Valve Stenosis

Keywords

Angiotensin II Receptor BlockersLeft ventricular remodelingValvular heart diseaseAortic stenosis

Outcome Measures

Primary Outcomes (1)

  • Change in the anatomic progression of aortic stenosis

    Aortic valve calcification (measured by MDCT)

    Baseline, 2 years

Secondary Outcomes (5)

  • Change in peak aortic jet velocity

    Baseline, 2 years

  • Change in aortic valve area

    Baseline, 2 years

  • Change in left ventricular (LV) dimension

    Baseline, 2 years

  • Change in left ventricular (LV) mass

    Baseline, 2 years

  • Change in left ventricular (LV) fibrosis

    Baseline, 2 years

Study Arms (2)

Angiotensin Receptor Blockers

EXPERIMENTAL

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

Drug: Angiotensin Receptor Blockers

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Angiotensin Receptor BlockersDRUG

Angiotensin Receptor Blockers treatment for 2 years.

Angiotensin Receptor Blockers
PlaceboOTHER

Placebo administration for 2 years.

Placebo

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRIUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisVentricular RemodelingHeart Valve Diseases

Interventions

Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Marie-Annick Clavel, PhD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Annick Clavel, PhD

CONTACT

418-656-8711Marie-Annick.Clavel@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

June 4, 2021

Study Start

February 1, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

December 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)CA(1)