Use of SGLT2i in noHCM With HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401343
• Other study ID #: 2022-ZX006
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2max on cardiopulmonary exercise tesing		12 months
Secondary	NT-ProBNP		12 months
Secondary	NYHA heart failure classification		12 months
Secondary	KCCQ-CSS		12 months
Secondary	HCMSQ-(SoB)		12 months
Secondary	E/A		12 months
Secondary	E/e'		12 months
Secondary	Peak tricuspid regurgitation velocity		12 months
Secondary	Left atrium volume index , LAVI		12 months
Secondary	Left Ventricular Mass index, LVMI		12 months