Heart Failure and Kidney Function Study

About this study

Do you suffer from Heart Failure and Renal Impairment?

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.

Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule

The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.

Would you like to take part?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with heart failure, and whether it will be made widely available to all Canadians who struggle with this condition. Study volunteers are an important part of moving medical care forward.

Who may qualify

You may qualify if

Are 18 years of age or older
Have a documented diagnosis of symptomatic heart failure
Have had a recent heart failure event within 6 months (hospitalization or urgent visit)
Have a LVEF value from an assessment within the last 12 months
Have managed your condition with SoC therapy for heart failure and renal impairment according to local guidelines

This study may not be a fit if

Have experienced acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
Have had major cardiac surgery, coronary revascularization or valvular repair or replacement, or implantation of a Cardiac resynchronization therapy device within 3 months prior to enrolment or planned to undergo any of these operations
Have a history of hypertrophic obstructive cardiomyopathy
Have complex congenital heart disease or severe uncorrected primary valvular disease
Have symptomatic bradycardia or second- or third-degree heart block without a pacemaker
Have systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours
Have primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
Have type 1 diabetes mellitus
Have had kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
Have hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening
Have a suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
Are treatmed with strong or moderate CYP3A4 inhibitor or induce

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: ≈3 years — 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

WATERLOO, ONThe Boardwalk Medical CentrePrincipal investigator: Dr. Mohan Babapulle, Dr. Amelia YipView 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 →

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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.

Who may take part in this study?

Myself

Someone I care for

Age of the person who may take part

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

Has a doctor diagnosed you (or the person who may take part) with the condition this study is about?

Yes

Not sure

Postal code (first 3 characters are enough)

Heart Failure and Impaired Kidney Function Research Study

About this study

Who may qualify

What participation may involve

What participants may receive

Where this study is enrolling

Learn more

Cardiovascular disease

Other studies you can explore

Common questions

Ask the research site to contact you

See if you may qualify

How can we reach you?

Find a study

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