Use of SGLT2i in noHCM With HFpEF

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06401343

Enrollment

Registered

2024-05-06

Start date

2022-08-01

Completion date

2025-08-01

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy

Brief 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.

Interventions

DRUGEmpagliflozin 10 MG

Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
VO2max on cardiopulmonary exercise tesing	12 months

Secondary

Measure	Time frame
NYHA heart failure classification	12 months
KCCQ-CSS	12 months
HCMSQ-(SoB)	12 months
E/A	12 months
NT-ProBNP	12 months
Peak tricuspid regurgitation velocity	12 months
Left atrium volume index , LAVI	12 months
Left Ventricular Mass index, LVMI	12 months
E/e'	12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026