Evaluating Empagliflozin in patients with nonobstructive hypertrophic cardiomyopathy and heart failure
Sodium-dependent Glucose Transporters 2 Inhibitor in Nonobstructive Hypertrophic Cardiomyoapthy Patients With Heart Failure With Preserved Ejection Fraction: a Prospective, Multi-center,Open-lable,Randomized Controlled Trial
This study is testing if the medication Empagliflozin can help improve exercise ability, heart failure symptoms, and overall quality of life for adults with nonobstructive hypertrophic cardiomyopathy and heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06401343 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of the SGLT2 inhibitor Empagliflozin on exercise capacity, heart failure symptoms, cardiac function, myocardial remodeling, and quality of life in patients with nonobstructive hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF). Participants must be at least 18 years old and have specific heart function metrics, including elevated NT-proBNP levels. The intervention involves administering Empagliflozin at a dosage of 10 mg. The study aims to provide insights into the potential benefits of this medication for improving outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with nonobstructive hypertrophic cardiomyopathy and heart failure with preserved ejection fraction.
Not a fit: Patients with recent heart failure decompensation, significant renal insufficiency, or those undergoing specific heart procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve exercise capacity and quality of life for patients with nonobstructive HCM and HFpEF.
How similar studies have performed: While the use of SGLT2 inhibitors in heart failure is gaining attention, this specific application in nonobstructive HCM and HFpEF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.