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Use of SGLT2i in noHCM With HFpEF

Use of SGLT2i in noHCM With HFpEF

Recruiting
18 years and older
All
Phase 4

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Overview

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 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.

Study details
    Hypertrophic Cardiomyopathy
    Heart Failure With Preserved Ejection Fraction

NCT06401343

China National Center for Cardiovascular Diseases

16 May 2024

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