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The use of empagliflozin in patients with hypertrophic cardiomyopathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517643-31-00
Acronym
EMPA-REPAIR-HCM
Enrollment
250
Registered
2024-11-11
Start date
2022-06-22
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic cardiomyopathy

Brief summary

A test of the null hypothesis that the mean VO 2 max measured 12 months after randomization is the same in the treatment group and the placebo group;, A null hypothesis test that the mean KCCQ-OS value measured 12 months after randomization is the same in the treatment group and the placebo group.

Detailed description

The secondary objective of the trial is to test the null hypothesis that the mean value of the VO 2 max measured 12 months after randomization is the same in the treatment group treated group and the placebo group among patients with reduced left ejection fraction ventricle.

Interventions

DRUGMicrocrystalline cellulose
DRUGmagnesium stearate
DRUGJardiance 10 mg film-coated tablets

Sponsors

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
A test of the null hypothesis that the mean VO 2 max measured 12 months after randomization is the same in the treatment group and the placebo group;, A null hypothesis test that the mean KCCQ-OS value measured 12 months after randomization is the same in the treatment group and the placebo group.

Secondary

MeasureTime frame
The secondary objective of the trial is to test the null hypothesis that the mean value of the VO 2 max measured 12 months after randomization is the same in the treatment group treated group and the placebo group among patients with reduced left ejection fraction ventricle.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026