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Home/Current studies/A Study for People With Type 2 Diabetes,…
Limited enrolment now · Enrolment is limited

A Study for People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Open to adults managing all three conditions — with no history of heart failure.
Enrolling at: Montreal · Stouffville
Phase 3Study phase
≈12 monthsStudy length
10–12 visitsAt the research site
18+Age range
3 sitesResearch locations

About this study

Do you suffer from Type 2 Diabetes, High Blood Pressure and Cardiovascular Disease?

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.

Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.

Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.

Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants’ health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants’ health and take note of any unwanted effects.

Would you like to take part in this research study?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.

Who may qualify

You may qualify if
  • Are at least 18 years old at time of consent
  • Provide signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Are a woman of childbearing potential (WOCBP): must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
  • Have a medical history of hypertension and on active pharmacological treatment
  • Have a medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
  • Have an established cardiovascular (CV) disease and are on active pharmacological treatment
  • Have at least one additional risk factor for developing heart failure (HF)
This study may not be a fit if
  • Have a history of heart failure (HF) or hospitalization for HF or treatment of HF
  • Experience atrial fibrillation or atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
  • Have any advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
  • Have been treated with a Mineralocorticoid receptor antagonist (MRA)
  • Have been treated with amiloride or other potassium-sparing diuretic
  • Are receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomization), or planned during the trial:
    • A direct renin inhibitor (e.g. aliskiren)
    • More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
    • Other aldosterone synthase inhibitors (e.g. baxdrostat)
    • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply
Every study has additional criteria the research site will review with you.

What participation may involve

  • Regular visits with the study team at no cost
  • Study assessments and health monitoring throughout
  • Check-ins between visits
  • Informed consent before anything begins — questions welcome
Time commitment: ≈12 months with 10–12 visits — confirmed by the research site. The full visit schedule is explained during informed consent.

What participants may receive

  • Study-related care from a physician-led team
  • Study assessments at no cost
  • Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.
Participating research sites

Where this study is enrolling

MONTREAL, QCEndocrinologie OasisPrincipal investigator: Dr. Zeina YaredView site →STOUFFVILLE, ONStouffville Medical CentrePrincipal investigator: Dr. Nima Mirtorabi, Dr. Sarah Barclay, Dr. Douglas WuView site →MONTREAL, QCTHEO Médical - SalaberryPrincipal investigator: Dr. Maria ValoisView site →

Learn more

About the condition

Cardiovascular disease

Cardiovascular disease is a group of conditions affecting the heart and the blood vessels that carry blood around your body. The most common form in Canada is ischemic…

Learn about this condition →
About the condition

Diabetes

Diabetes means the level of sugar, or glucose, in your blood stays too high because your body cannot make enough insulin or cannot use the insulin it makes.…

Learn about this condition →
About the condition

Hypertension (high blood pressure)

Blood pressure is the force of blood pushing against the walls of your arteries. Hypertension, or high blood pressure, means that force stays higher than it should over…

Learn about this condition →
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CardiovascularThe Future of Longevity: What’s Coming NextRead →Alzheimer’s & DementiaPreventive Medicine: Extending Health Span, Not Just LifespanRead →Alzheimer’s & DementiaLongevity Drugs: From Diabetes Treatments to Anti-Aging ResearchRead →

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Common questions

Do I have to decide now?
No. Answering the questions is not a commitment — it simply lets the research team see whether this study may be appropriate and contact you to talk it through.
Will it cost me anything?
No. Study visits and study assessments are provided at no cost, and reasonable travel may be reimbursed where applicable.
What happens after I submit the form?
A member of the research team reviews your answers and contacts you — usually within two business days — to answer questions and review the next steps.
Could I receive a placebo?
Some studies compare a treatment with a placebo. Whether this study does is explained clearly during informed consent, before you decide anything.
Can I leave the study after it starts?
Yes. Participation is always voluntary. You can withdraw at any time without giving a reason and without it affecting your regular medical care.
Request contact

Ask the research site to contact you

Your answers go only to the research site, help the team prepare before they call — and completing the form doesn’t obligate you to take part.
JAS Study Interest (Stream A)

See if you may qualify

A few quick questions — about a minute. Your answers help the research team prepare before they contact you.

For anyone under 18, a parent or legal guardian should complete this form and would need to consent on their behalf.

See if you may qualify →

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