Phase 2 Heart Disease Trial, Recruiting NCT06182839 Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Condition: Heart Disease
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Phase 2 Heart Disease Trial, Recruiting

NCT06182839
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People with advanced kidney disease, meaning their kidneys are working at less than 20% of normal capacity and they are not yet on dialysis, OR people who started dialysis (either hemodialysis or peritoneal dialysis) within the last 6 months. (Note: for people who started dialysis after a sudden kidney crisis and were not previously seen in a kidney clinic, at least 90 days of dialysis may be required before joining — confirm details with the trial site.)
  • People who also have at least one of the following: an enlarged heart muscle (detected by imaging); a hospital stay for heart failure or a heart or blood vessel condition in the last 12 months; type 2 diabetes; or a high level of protein in their urine (this last condition does not apply to dialysis patients who produce less than 500 ml of urine per day).

Who may not be able to join:

  • People with type 1 diabetes.
  • People with a history of a serious condition called euglycemic ketoacidosis (a dangerous chemical imbalance in the blood, which can occur even when blood sugar is normal).
  • People with a known allergic reaction or sensitivity to a class of medications called SGLT-2 inhibitors.
  • People whose heart and circulation are currently unstable and require intravenous medications to keep the heart pumping.
  • People with a resting systolic blood pressure below 90 mmHg (very low blood pressure).
  • People with severe liver scarring (advanced cirrhosis, known medically as Child-Pugh class C).
  • People with active liver inflammation, indicated by significantly elevated liver blood test results.
  • People who have recurring serious infections of the genitals or urinary tract.
  • People currently taking certain medications (digoxin, phenobarbital, phenytoin, rifampin, or ritonavir) that cannot be safely stopped, due to potential interactions with the trial drug.
  • People who have metal-containing cardiac devices implanted in their body (such as certain pacemakers or defibrillators) that are not safe for MRI scanning.
  • People with claustrophobia (fear of enclosed spaces), as the trial involves MRI scans.
  • People with cochlear implants (hearing devices implanted in the ear).
  • People with metal fragments or objects in or around their eyes.
  • People who are pregnant or breastfeeding.
  • People with any other medical condition that the trial doctor considers a reason not to participate.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Thomas Mavrakanas, MD, Research Institute of the McGill University Health Center

Phone: 514-934-1934

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
30 March 2028

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Change in left ventricular mass to volume ratio (LVMV) from baseline to 12 months, as assessed by cardiac MRI compared with placebo

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov