Vicadrostat with empagliflozin for people with type 2 diabetes, high blood pressure, and heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who meet the criteria are randomly assigned to one of two groups: vicadrostat plus empagliflozin or a placebo matching vicadrostat plus empagliflozin. Participants take one tablet daily and continue their usual medications for diabetes, blood pressure, and cardiovascular disease. Treatment and follow-up continue for a minimum of about 2½ years and up to roughly 4 years and 3 months to track cardiovascular outcomes. The study is placebo-controlled with matching tablets to maintain blinding between the active and placebo vicadrostat groups.

Why it matters

Who can join: the full rules

Inclusion Criteria :

* At least 18 years old at time of consent
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
* Participants with medical history of hypertension and on active pharmacological treatment
* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
* Established cardiovascular (CV) disease and on active pharmacological treatment
* At least one additional risk factor for developing heart failure (HF)

Exclusion Criteria:

* History of HF or hospitalization for HF or treatment of HF
* Atrial fibrillation or Atrial flutter with a resting heart rate \>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
* Treatment with an Mineralocorticoid receptor antagonist (MRA)
* Treatment with amiloride or other potassium-sparing diuretic
* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), 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.

Where it's running

• Pinnacle Research Group, LLC
  Anniston, Alabama, United States Recruiting
• Eastern Shore Research Group
  Fairhope, Alabama, United States Recruiting
• Lakeview Clinical Research
  Guntersville, Alabama, United States Recruiting
• Arizona Clinical Trials - Chandler
  Chandler, Arizona, United States Recruiting
• Elite Clinical Studies
  Phoenix, Arizona, United States Recruiting
• Clinical Research Institute of Arizona, LLC
  Sun City West, Arizona, United States Recruiting

+1092 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.