Hypertrophic CardiomyopathyPhase 4NCT06401343
Use of SGLT2i in noHCM With HFpEF
A Phase 4 study testing Empagliflozin 10 MG in people with Hypertrophic Cardiomyopathy and Heart Failure With Preserved Ejection Fraction, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Lianming Kang, +86 88396870, lianmingkang@126.com
About this study
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
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.
- Being tested
- Empagliflozin 10 MG
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Participants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Use of Empagliflozin+guideline directed medical treatment of HCM Receives: Drug: Empagliflozin 10 MG |
| Control group | No intervention | Guideline directed medical treatment of HCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max on cardiopulmonary exercise tesing
Measured: 12 months
Secondary outcomes (9)
NT-ProBNP
Measured: 12 months
NYHA heart failure classification
Measured: 12 months
KCCQ-CSS
Measured: 12 months
HCMSQ-(SoB)
Measured: 12 months
E/A
Measured: 12 months
E/e'
Measured: 12 months
Peak tricuspid regurgitation velocity
Measured: 12 months
Left atrium volume index , LAVI
Measured: 12 months
Left Ventricular Mass index, LVMI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Aug 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lianming Kang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401343
- Sponsor's protocol ID
- 2022-ZX006
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06401343
- Acronym / sponsor ID
- 2022-ZX006
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Empagliflozin 10 MGUse of Empagliflozin+guideline directed medical treatment of HCM |
| Control group | No intervention | –Guideline directed medical treatment of HCM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGParticipants randomized to the study group will received Empagliflozin 10mg q.d. for 12 months. | Drug | Study group |
Primary outcome
VO2max on cardiopulmonary exercise tesing
Time frame: 12 months
9 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
Related trials for Hypertrophic Cardiomyopathy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with Hypertrophic Cardiomyopathy and Heart Failure With Preserved Ejection Fraction, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max on cardiopulmonary exercise tesing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.