Use of SGLT2i in noHCM With HFpEF

NCT ID: NCT06401343

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Use of Empagliflozin+guideline directed medical treatment of HCM

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

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

Control group

Guideline directed medical treatment of HCM

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Empagliflozin 10 MG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lianming Kang

Dr. Lianming Kang

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Lianming Kang

Role: primary

+86 88396870

Other Identifiers

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2022-ZX006

Identifier Type: -

Identifier Source: org_study_id

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