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Use of SGLT2i in noHCM With HFpEF

RECRUITINGPhase 4Sponsored by China National Center for Cardiovascular Diseases
Actively Recruiting
PhasePhase 4
SponsorChina National Center for Cardiovascular Diseases
Started2022-08-01
Est. completion2024-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Heart DiseaseHeart Failure With Preserved Ejection FractionHypertrophic Cardiomyopathy

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