RecruitingNCT06401343Updated May 6, 2024

Use of SGLT2i in noHCM With HFpEF

A Phase 4 interventional study of Empagliflozin 10 MG in Hypertrophic Cardiomyopathy and Heart Failure With Preserved Ejection Fraction, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
Registered 1 year 9 months after the study started (first participant enrolled Aug 2022, registered May 2024).
Started Aug 2022; still recruiting 4 years 2 months later.

Phase: Phase 4
Study type: Interventional
Enrollment: 94
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hypertrophic Cardiomyopathy
Heart Failure With Preserved Ejection Fraction

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 94 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

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Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 94 participants (estimated)

Study arms

Experimental
Study group
Use of Empagliflozin+guideline directed medical treatment of HCM
Drug: Empagliflozin 10 MG
No intervention
Control group
Guideline directed medical treatment of HCM

Interventions

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

What researchers measure

Primary outcomes

VO2max on cardiopulmonary exercise tesing
Time frame: 12 months

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing 100037, China
- Lianming Kang · Contact · lianmingkang@126.com · +86 88396870
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06401343
Lead sponsor: China National Center for Cardiovascular Diseases
Responsible party: Lianming Kang (Dr. Lianming Kang, China National Center for Cardiovascular Diseases) — Principal investigator
First posted: May 6, 2024
Start date: Aug 1, 2022
Primary completion: Aug 1, 2024 (estimated)
Completion: Aug 1, 2025 (estimated)
Last update: May 6, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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