Finerenone and Empagliflozin for Heart Failure

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Recruiting Phase 3 Interventional Study
Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,500 (estimated)
Sponsor
Colorado Prevention Center · Other
Who this trial is looking for

This trial is looking for adults who are currently hospitalized or recently discharged with heart failure. Participants will receive a combination of two medications to see how well they work compared to standard care.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesSevere hyperkalemia

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with heart failure.
  • I have signs and symptoms of heart failure when admitted to the hospital.
  • I have had a specific heart test showing high levels of certain peptides.
  • I have received at least one intravenous dose of a loop diuretic during my hospitalization.
  • I can provide consent to participate.
  • I am a female participant and have had a negative pregnancy test.
  • I agree to use adequate contraception during the trial.

You may not be able to join if

  • I have type 1 diabetes.
  • I have a history of severe high potassium levels with certain medications.
  • I have been treated with specific diabetes medications recently.
  • I have severe kidney issues.
  • I have had a heart attack or similar serious heart procedures in the last 30 days.
  • I have had or will have a heart transplant.
  • I have significant uncorrected heart valve disease.
  • I have a different serious cause for my heart failure symptoms.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations * Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * Current hospitalization or rec…
Contacts

Marc Bonaca

(303) 860-9900

info@cpcmed.org

CONTACT