Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
94 participants
INTERVENTIONAL
2022-08-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Use of Empagliflozin+guideline directed medical treatment of HCM
Empagliflozin 10 MG
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
Control group
Guideline directed medical treatment of HCM
No interventions assigned to this group
Interventions
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Empagliflozin 10 MG
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Lianming Kang
Dr. Lianming Kang
Locations
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Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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2022-ZX006
Identifier Type: -
Identifier Source: org_study_id
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