Use of SGLT2i in noHCM With HFpEF

National Center for Cardiovascular Diseases

Status and phase: Enrolling; Phase 4

Conditions: Heart Failure With Preserved Ejection Fraction; Hypertrophic Cardiomyopathy

Treatments: Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06401343

2022-ZX006

Details and patient eligibility

About

This study aims to evaluate the impact of Sodium-dependent glucose transporters 2 inhibitor Empagliflozin on the exercise capacity,symptoms of heart failure, cardiac function, myocardial remodeling and quality of life of nonobstructive HCM patients with HFpEF.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of nonobstructive hypertrophic cardiomyopathy;
• At least 18 years old;
• LVEF≥50%
• Elevated NT-proBNP >300 pg/ml for patients without atrial fibrillation (AF), or >900 pg/ml for patients with AF at Visit 1;
• NYHA II-IV
• Capable of performing cardiopulmonary exercise test with an RER≥1.0
• Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion criteria

• Under-went septal reduction therapy within 3 months before screening;
• Acute decompensation heart failure within 3 months before screening;
• Symptomatic low BP or SBP<100mmHg;
• eGFR<30ml/min/1.73m2
• LVOTG ≥30mmHg at rest or under provocation;
• Renal insufficiency with eGFR<50mL/min/1.73m2
• ICD implantation or CRT planned within 3 months;
• Women who are pregnant, or who plan to become pregnant while in the trial;
• Currently enrolled in another investigational device or drug trial;
• Combining any other clinical condition with a life expectancy less than 1 year.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Study group

Experimental group

Description:

Use of Empagliflozin+guideline directed medical treatment of HCM

Treatment:

Drug: Empagliflozin 10 MG

Control group

No Intervention group

Description:

Guideline directed medical treatment of HCM