Use of SGLT2i in noHCM With HFpEF

NCT06401343 | Recruiting Phase 4

• 1 other identifier: 2022-ZX006
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• VO2max on cardiopulmonary exercise tesing

  12 months

Secondary Outcomes (9)

• NT-ProBNP

  12 months

• NYHA heart failure classification

  12 months

• KCCQ-CSS

  12 months

• HCMSQ-(SoB)

  12 months

• E/A

  12 months

Study Arms (2)

Study group

EXPERIMENTAL

Use of Empagliflozin+guideline directed medical treatment of HCM

Drug: Empagliflozin 10 MG

Control group

NO INTERVENTION

Guideline directed medical treatment of HCM

Interventions

Empagliflozin 10 MG DRUG

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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lianming Kang

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)