NCT07240844

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.

Detailed description

Patients with a confirmed diagnosis of cardiac amyloidosis and symptomatic heart failure (NYHA class II-III) will be recruited. Participants will be randomized to receive either the study drug or placebo and will undergo baseline and 12-week assessments, including the Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test, and cardiopulmonary exercise testing. Following a 4-week washout period, participants will cross over to the alternate treatment arm (study drug or placebo) and repeat the same assessments at baseline and 12 weeks. The primary endpoint will be the change in KCCQ Clinical Summary Score (KCCQ-CSS).

Conditions

• Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Enavogliflozin 0.3mg	Participants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
DRUG	Placebo	Participants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-04-29
• Completion: 2027-05-31
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

2 sites across 1 country: South Korea