Sodium-dependent Glucose Transporters 2 Inhibitor in Nonobstructive Hypertrophic Cardiomyoapthy Patients With Heart Failure With Preserved Ejection Fraction: a Prospective, Multi-center,Open-lable,Randomized Controlled Trial

China National Center for Cardiovascular Diseases1 site in 1 country94 target enrollmentAugust 1, 2022

ConditionsHypertrophic Cardiomyopathy Heart Failure With Preserved Ejection Fraction

InterventionsEmpagliflozin 10 MG

Overview

Phase: Phase 4
Intervention: Empagliflozin 10 MG
Conditions: Hypertrophic Cardiomyopathy
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 94
Locations: 1
Primary Endpoint: VO2max on cardiopulmonary exercise tesing
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

August 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Principal Investigator

Lianming Kang

Dr. Lianming Kang

China National Center for Cardiovascular Diseases

Eligibility Criteria

Inclusion Criteria

•Patients with a diagnosis of nonobstructive hypertrophic cardiomyopathy;
•At least 18 years old;
•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.