RECRUITINGPhase 4INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form and willing to return for clinical follow-up.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Empagliflozin 10 MG
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
Locations (1)
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China