Actively Recruiting
Use of SGLT2i in noHCM With HFpEF
Led by China National Center for Cardiovascular Diseases · Updated on 2024-05-06
94
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Use of SGLT2i in noHCM With HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of nonobstructive hypertrophic cardiomyopathy
- Age 18 years or older
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Elevated NT-proBNP over 300 pg/ml (without atrial fibrillation) or over 900 pg/ml (with atrial fibrillation) at first visit
- New York Heart Association (NYHA) class II to IV symptoms
- Able to perform cardiopulmonary exercise test with respiratory exchange ratio (RER) of 1.0 or higher
- Signed informed consent and willing to return for follow-up visits
You will not qualify if you...
- Septal reduction therapy within 3 months before screening
- Acute decompensated heart failure within 3 months before screening
- Symptomatic low blood pressure or systolic blood pressure below 100 mmHg
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2
- Left ventricular outflow tract gradient (LVOTG) 30 mmHg or higher at rest or with provocation
- Renal insufficiency with eGFR less than 50 ml/min/1.73 m2
- Implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) planned within 3 months
- Pregnant women or those planning pregnancy during the study
- Current participation in another investigational drug or device trial
- Any other serious clinical condition with life expectancy under 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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