Use of SGLT2i in noHCM With HFpEF

Phase 4

Recruiting

• Conditions: Hypertrophic Cardiomyopathy; Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: Empagliflozin 10 MG

• Registration Number: NCT06401343
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Empagliflozin 10 MG	Use of Empagliflozin+guideline directed medical treatment of HCM

Primary Outcome Measures

Name	Time	Method
VO2max on cardiopulmonary exercise tesing	12 months

Secondary Outcome Measures

Name	Time	Method
NT-ProBNP	12 months
HCMSQ-(SoB)	12 months
NYHA heart failure classification	12 months
E/A	12 months
KCCQ-CSS	12 months
Peak tricuspid regurgitation velocity	12 months
Left atrium volume index , LAVI	12 months
Left Ventricular Mass index, LVMI	12 months
E/e'	12 months

Trial Locations

Locations (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China