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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
View on ClinicalTrials.gov →
NCT06401343
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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Actively Recruiting
PhasePhase 4
SponsorChina National Center for Cardiovascular Diseases
Started2022-08-01
Est. completion2024-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06401343