Use of SGLT2i in noHCM With HFpEF
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 Diseases
94 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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.
Interventions
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06401343