Use of SGLT2i in noHCM With HFpEF

May 2, 2024 updated by: Lianming Kang, China National Center for Cardiovascular Diseases

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Use of Empagliflozin+guideline directed medical treatment of HCM
Drug: Empagliflozin 10 MG
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
No Intervention: Control group
Guideline directed medical treatment of HCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VO2max on cardiopulmonary exercise tesing
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-ZX006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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