Finerenone / Heart Failure / empagliflozin · Phase 3 Trial

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

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration comparing finerenone plus empagliflozin combination therapy to usual care in hospitalized heart failure patients. The study is actively recruiting with a planned sample of 1500 participants and 6-month follow-up for clinical benefit and safety outcomes. No efficacy or safety results have been posted to the registry.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Heart Failure; age from 18 Years. Intervention: Finerenone plus empagliflozin. Compared with: Usual care — No Intervention. n = 1,500. 140 sites across 8 countries.

Key findings

Safety

No efficacy or safety outcomes can be assessed from this registry entry.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registry record with no posted results; the study is actively recruiting and efficacy and safety outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Clinical benefit (assessed at 6 months); Number of serious adverse events (AEs). (assessed at 6 months); Number of adverse events leading to discontinuation of study drug. (assessed at 6 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationHeart Failure; age from 18 Years

Sample size1,500

InterventionFinerenone plus empagliflozin

ComparatorUsual care — No Intervention

Setting140 sites across 8 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment1500

Study phasePHASE 3

Primary outcome measure 1Clinical benefit at 6 months

Primary outcome measure 2Number of serious adverse events at 6 months

Primary outcome measure 3Number of adverse events leading to discontinuation at 6 months

Caveats

This is a registry record only; no results have been posted or published.
No baseline characteristics, inclusion/exclusion criteria, or randomization details provided.
Blinding status and allocation concealment method not reported.
No efficacy or safety outcomes can be assessed from this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 interventional randomized controlled trial design.

Directness

strong

Hospitalized heart failure patients; finerenone plus empagliflozin combination.

Consistency

insufficient

No results posted; cannot assess consistency with prior evidence.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or conduct details.

Sample adequacy

strong

Planned enrollment 1500 participants; adequate for Phase 3 efficacy study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06024746). This is a study registration, not published results. Lead sponsor: Colorado Prevention Center. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DRUG: Finerenone; DRUG: Empagliflozin. Primary outcome measures: Clinical benefit , 6 months; Number of serious adverse events (AEs). , 6 months; Number of adverse events leading to discontinuation of study drug. , 6 months. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

FinerenoneNCT06024746Heart FailureColorado Prevention Centerempagliflozin